Radiesse (+) Lidocaine 8063M0K2Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI M2138063M0K25), received between Apr 19, 2017 and Dec 4, 2025 — classified as 61 injuries.

The most frequently reported specific device problem is “Off-Label Use” (7 reports).

3 other recalls cover devices cleared under the same FDA submission (P050052); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US CONSUMER AND CONCERNS A FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE IN THE TOP OF THE HANDS, IN(B)(6) 2025. BATCH NUMBER AND EXPIRY DATE WERE REPORTED AS UNKNOWN. IN 2025, AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED THAT THE INJECTION SITE TOOK A LONG TIME TO HEAL. IN 2025 (REPORTED AS BY JUNE), THE INJECTION SITE WAS NOT HEALED AND THE PATIENT EXPERIENCED NODULES IN BOTH HANDS. AS REPORTED, OVER THE NEXT FIVE MONTHS, THE AREA WAS FLOODED WITH NORMAL SALINE (REPORTED AS NS) TWICE, MICRONEEDLING WAS DONE TO THE AREA TWICE ALONG WITH CLEARV TREATMENTS, AND THE PATIENT RECEIVED KENALOG INJECTIONS TWICE. AFTER THE LAST KENALOG INJECTION, ONE NODULE OPENED UP AND THE RADIESSE (ALSO REPORTED AS THE PRODUCT) WAS COMING OUT OF THE OPENING/EXTRUDING OUT. THE PATIENT WAS SCHEDULED WITH A PHYSICIAN WHO WAS GOING TO EXCISE THE AREAS ON (B)(6) 2025. AT THE TIME OF THIS REPORTED, THE PATIENTS' HANDS HAD MULTIPLE NODULES AND WERE VERY UNSIGHTLY. DUE TO THE INFORMATION PROVIDED, THE OUTCOME FOR THE EVENTS NODULES AND INJECTION SITE DID NOT HEAL WAS CONSIDERED NOT RESOLVED, THE OUTCOME FOR THE EVENT RADIESSE WAS E

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deposits; No Clinical Signs, Symptoms or Conditions; Nodule; Unspecified Tissue Injury

  MAUDE report 23715581 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE (+) INTO THE HANDS, ON (B)(6) 2024. ONE SYRINGE OF RADIESSE (+) WAS INJECTED INTO EACH HAND, USING A 23 G CANNULA. IN (B)(6) 2025, AFTER THE RADIESSE (+) INJECTION, THE PATIENT EXPERIENCED MULTIPLE BUMPS ALL OVER THE HANDS, INCLUDING ONE VERY LARGE SPONGY LUMP ON THE LEFT-HAND MEASURING APPROXIMATELY 2.5 CM TIMES 3.8 CM. IN (B)(6) 2025, 1 ML OF 5-FLUOROURACIL, 0.5 ML OF DEXAMETHASONE 4 MG, AND 0.1 ML OF KENALOG 10 MG/ML WERE MIXED IN 1 SYRINGE FOR THE TREATMENT OF NODULES. IN (B)(6) 2025, NO CHANGES WERE OBSERVED IN NODULES. THE PATIENT WAS TREATED WITH COLCHICINE 1.2 MG ORALLY, AS A SINGLE LOADING DOSE (REPORTED AS 1.2 MG/D PO ONE DAY), FOLLOWED BY COLCHICINE 0.6 MG ORALLY TWICE DAILY FOR 5 DAYS. IN (B)(6) 2025, NO CHANGES IN NODULES WERE NOTED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED. FOLLOW-UP INFORMATION WAS RECEIVED ON 02-OCT-2025: THIS CASE WAS UPGRADED TO SERIOUS. THE REPORTED TERM BUMPS WAS CHANGED TO BUMPS/LUMPS/GRANULOMATOUS REACTION AND THE CODING REMAINED UNCHANGED. THE PATIENTS INITIAL

  Patient problems: Nodule

  MAUDE report 23299907 ↗
• InjuryAug 22, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Migration; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Migration

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE INTO THE TEMPLE AREA (OFF LABEL USE OF DEVICE). AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED SWELLING AND BRUISING SURROUNDING EYE. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 14-AUG-2025: THIS CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE (+). THE EVENTS RIDGE/PRODUCT MIGRATION AND WHITE WERE ADDED. EVENT TERM WAS CHANGED FROM BRUISING TO BRUISING/BLACK AND BLUE, CODING REMAINS UNCHANGED. THE PATIENT'S INITIALS, DATE OF BIRTH, GENDER, AND WEIGHT (REPORTED AS APPROXIMATELY 54 KG) WERE PROVIDED. SHE WAS 58 YEARS OLD AT THE TIME OF THE EVENT. THE PATIENT WAS INJECTED BILATERALLY WITH 1.5 ML OF RADIESSE (+) INTO THE TEMPLE AREA (OFF LABEL USE OF DEVICE) ON (B)(6) 2025. BATCH NUMBER WAS REPORTED AS A00169980 (EXPIRY DATE: 14-SEP-2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE (+) WAS CONFIRMED AS A00169980 (EXPIRY DATE: 14-SEP-2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE PATIENT WAS PREVIOUSLY INJECTED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bruise/Contusion; No Clinical Signs, Symptoms or Conditions; Skin Discoloration

  MAUDE report 22874219 ↗
• InjuryAug 13, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE (+) INTO THE HANDS. BATCH NUMBER WAS REPORTED AS A00170010 (EXPIRY DATE: SEP-2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00170010 (EXPIRY DATE: SEP-2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. ONE SYRINGE OF RADIESSE (+) WAS DILUTED WITH 0.5 ML OF NORMAL SALINE (REPORTED AS NS) (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE) AND WAS INJECTED PER HAND. FIVE DAYS AFTER THE RADIESSE (+) INJECTION, THE PATIENT EXPERIENCED EDEMA, ERYTHEMA, WARMTH AND COMPLAINED OF (REPORTED AS C/O) PAIN, IN THE LEFT HAND. CAPILLARY REFILL WAS REPORTED AS GOOD. THE PATIENT WAS ON ANTIBIOTICS AND STEROIDS. THE HEALTH CARE PROFESSIONAL STATED THE SWELLING WAS CONSISTENT AND THE REDNESS COMES AND GOES. THERE WERE NO COMPLAINTS FOR THE RIGHT HAND. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT EDEMA/SWELLING WAS CONSIDERED AS NOT RESOLVED. THE OUTCOME OF THE EVENTS WARMTH, ERYTHEMA, AND PAIN WAS UNKNOWN. FOLLOW- INFORMATION WAS RECEIVED ON 17-JUL-2025: THIS CASE W

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Infection

  MAUDE report 22794062 ↗
• InjuryJul 16, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE INTO THE NECK (OFF LABEL USE OF DEVICE), IN (B)(6) 2025, REPORTED AS 2 MONTHS PRIOR TO THE TIME OF THIS REPORT. RADIESSE WAS HYPERDILUTED AT A 2:1 RATIO. IN 2025, 3 WEEKS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED NODULES ON THE INTERIOR PART OF THE NECK. HEALTH CARE PROFESSIONAL TREATED NODULES WITH HYALURONIDASE, WITH NO IMPROVEMENT, AND WANTED TO KNOW PROTOCOL FOR TREATING THE NODULES. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED. FOLLOW-UP INFORMATION WAS RECEIVED ON JULY 8, 2025: THIS CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). PATIENTS INITIALS, DATE OF BIRTH, AGE, GENDER (FEMALE) AND WEIGHT (54 KG) WERE PROVIDED. SHE WAS 52 YEARS OLD AT THE TIME OF THE EVENT. THE PATIENT WAS INJECTED WITH A TOTAL OF 3 ML OF RADIESSE(+), ON (B)(6) 2025. BATCH NUMBER WAS REPORTED AS A00163350 (EXPIRY DATE: SEPTEMBER 1, 2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00163350 (EXPIRY DATE: SEPTE

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nodule; Skin Discoloration

  MAUDE report 22522815 ↗
• InjuryJul 1, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE(+) INTO THE RIGHT SIDE OF THE FACE (ALSO REPORTED AS THE RIGHT SIDE), ON AN UNKNOWN DATE. BATCH NUMBER WAS REPORTED AS UNKNOWN. ON AN UNKNOWN DATE, AFTER INJECTION WITH RADIESSE(+), THE PATIENT EXPERIENCED NUMBNESS AND TINGLING IN THE RIGHT SIDE OF THE FACE, AS WELL AS A HEADACHE AND PAIN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 18-JUN-2025: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS NUMBNESS AND TINGLING, HEADACHE AND PAIN WERE DELETED. THE EVENT NERVE INJURY WAS ADDED. THE PATIENTS AGE, DATE OF BIRTH AND WEIGHT (61 KG, REPORTED AS 135 LBS) WERE PROVIDED. SHE WAS 43 YEARS OLD (AMBIGUOUSLY REPORTED AS 44) AT THE TIME OF THIS REPORT. THE PATIENT WAS INJECTED WITH RADIESSE(+), INTO THE CHEEKS (OFF LABEL USE OF DEVICE), ON (B)(6) 2025. BATCH NUMBER WAS REPORTED AS A00158220 (EXPIRY DATE: 26-AUG-2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00158220 (EXPIRY DATE: 26-AUG-2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. HALF

  Patient problems: Nerve Damage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373350 ↗
• InjuryJun 16, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A 53-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE (+), ON (B)(6) 2025. BATCH NUMBER WAS REPORTED AS A00158040 (EXPIRY DATE: AUG-2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE (+) WAS CONFIRMED AS A00158040 (EXPIRY DATE: AUG-2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. RADIESSE (+) WAS DILUTED IN A 1:3 RATIO (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE). IN 2025, AFTER THE RADIESSE (+) INJECTION, THE PATIENT EXPERIENCED VISIBLE AND PALPABLE NODULE ON HER NECK. THE HEALTH CARE PROFESSIONAL WALKED HER THROUGH DISPERSION PROTOCOL AS WELL AS THE MCCARTHY ALGORITHM. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 23-MAY-2025: THIS CASE WAS UPGRADED TO SERIOUS. THE VERBATIM TERM NODULE WAS AMENDED TO NODULE/FOCAL ACCUMULATION, CODING REMAINS UNCHANGED. THE OUTCOME UPDATED TO NOT RESOLVED (PREVIOUSLY UNKNOWN). THE PATIENT WAS INJECTED SUBDERMALLY WITH RADIESSE (+) INTO HER NECK (OFF LABEL USE OF DEVICE), ON (B)(6) 2025. RADIESSE (+) WAS DILUTED IN A 1:3 RATIO. SHE HAD NO ISSUES. ON (B)(6

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nodule

  MAUDE report 22210912 ↗
• InjuryMar 18, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE (+) INTO THE TEMPLE (OFF LABEL USE OF DEVICE), ON (B)(6) 2025 (REPORTED AS TUESDAY PRIOR TO THE DATE OF THIS REPORT). BATCH NUMBER WAS REPORTED AS UNKNOWN. RADIESSE (+) WAS HYPERDILUTED (REPORTED AS RHD) (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE) IN A 2:1 RATIO AND INJECTED USING A 25G, 1.5 INCH NEEDLE. IN (B)(6) 2025, AFTER THE RADIESSE (+), THE PATIENT EXPERIENCED A SUSPECTED OCCLUSION IN THE TEMPLE. ON THURSDAY (B)(6) 2025, AT 22:45 (REPORTED AS NIGHT AT 1045), THE PATIENT STATED SHE HAD SOME DISCOLORATION TO HER TEMPLE. IT WAS SPREADING NEAR THE EYE, DOWN THE CHEEK AND UP, NEAR THE FOREHEAD, WITH NOTED LIVEDO RETICULARIS. THE PATIENT DID NOT HAVE ANY PAIN OR VISION LOSS. CAPILLARY REFILL WAS 2-3 SECONDS. PHYSICIAN SENT PATIENT TO ANOTHER LOCAL INJECTOR TO ASSESS UNDER ULTRASOUND (REPORTED AS U/S) AND PLAN TREATMENT. THE OUTCOME OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 21634201 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN US PHYSICIAN AND CONCERNS A MALE PATIENT. THE PATIENT WAS INJECTED WITH A TOTAL OF 1.5 ML OF RADIESSE(+) INTO THE LEFT (AS REPORTED), ON (B)(6) 2024 (REPORTED AS ON FRIDAY). BATCH NUMBER WAS REPORTED AS A00145480 (EXPIRY DATE: 22-FEB-2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00145480 (EXPIRY DATE: 22-FEB-2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. IN NOVEMBER 2024, AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION. ON (B)(6) 2024, IN THE MORNING, THE PATIENT CALLED THE PHYSICIAN AND SENT A PICTURE. HE WAS TOLD TO COME TO THE PHYSICIANS OFFICE WHERE THE PHYSICIAN SAW THE VASCULAR OCCLUSION. THE OUTCOME OF THE EVENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20819473 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FORM A US HEALTH CARE PROFESSIONAL AND CONCERNS A 62-YEAR-OLD PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE INTO THE NECK, FOR LAXITY (OFF LABEL USE OF DEVICE), ON (B)(6) 2024. IN 2024, AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED NODULES IN THE NECK. ON (B)(6) 2024 (AMBIGUOUSLY REPORTED AS (B)(6)), THE PATIENT HAD RECHECKS (AS REPORTED). THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 10-OCT-2024: THIS CASE WAS UPGRADED TO SERIOUS. PRODUCT PREPARATION ISSUE WAS ADDED. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). VERBATIM TERM WAS AMENDED FROM NODULES TO NODULES/LUMPS, CODING REMAINS UNCHANGED. THE PATIENTS GENDER (FEMALE) WAS PROVIDED. SHE WAS INJECTED WITH RADIESSE(+), ON (B)(6) 2024. BATCH NUMBER WAS REPORTED AS A00121070 (EXPIRY DATE: 13-AUG-2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00121070 (EXPIRY DATE: 13-AUG-2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. RADIESSE(+) (1.5 ML) WAS MIXED WITH 4.5 ML OF NORMAL SALINE (PRODUCT PREPARATION ISSUE). THE PATIENT HAD 4 FRAXEL TREATMENTS IN THE AREAS TREATED WITH RADIESSE

  Patient problems: Nodule

  MAUDE report 20578464 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT PAIN WAS CONSIDERED TO BE A SYMPTOM OF VASCULAR OCCLUSION AND THEREFORE WAS NOT CODED. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A 39 YEAR OLD (1984), FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE(+), INTO THE CHIN (OFF LABEL USE OF DEVICE) ON THE MONDAY PRIOR TO THE DATE OF THIS REPORT. BATCH NUMBER WAS REPORTED AS A00117960 (EXPIRY DATE: 06/2025).THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00117960 (EXPIRY DATE: 06/2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED POSSIBLE OCCLUSION IN THE CHIN AREA. THE MANAGER STATED THE PATIENT PRESENTED WITH WHAT APPEARED TO BE AN OCCLUSION IN THE CHIN AREA, THEY THOUGHT THE PATIENT HAD A VASCULAR OCCLUSION BUT WAS NOT SURE. AS REPORTED, 12 HOURS AFTER THE INJECTION, THE PATIENT EXPERIENCED PAIN THAT TRAVELED TO LEFT CHEEK. ON A SCALE OF 1 TO 10 THE PAIN WAS REPORTED AS 12. THE PATIENT ALSO HAD PAIN IN HER GUMS. THE OUTCOME OF THE EVENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19512501 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE, IN (B)(6) 2023. AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A LUMP FORMING. SHE THOUGHT IT WOULD GO AWAY ON ITS OWN, HOWEVER, IT DID NOT. ON (B)(6) 2024, THE HEALTH CARE PROFESSIONAL SAW THE PATIENT. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 23-FEB-2024: THE CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THE EVENT VERBATIM WAS AMENDED FROM LUMP TO LUMP/NODULE AND THE CODING REMAINED UNCHANGED. THE PATIENTS INITIALS, AGE, DATE OF BIRTH (1952) AND WEIGHT (54.4 KG) WERE REPORTED. SHE WAS 71 YEARS OLD AT THE TIME OF THE EVENT (AMBIGUOUSLY REPORTED AS 72 YEARS OLD). SHE WAS INJECTED WITH 1.5 ML OF RADIESSE(+), INTO THE CHEEKS (OFF LABEL USE OF DEVICE), IN 2023. BATCH NUMBER WAS REPORTED AS A00049950. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00049950 (EXP. 02/2024). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. SHE WAS INJECTED WITH ABOUT 0.75 ML PER SIDE. THE PATIENT WAS PREVIOUSLY INJECTED WITH BELOTERO, R

  Patient problems: Nodule

  MAUDE report 18831641 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT (HERSELF). SHE WAS INJECTED SUBDERMALLY WITH APPROXIMATELY 0.2 ML OF RADIESSE(+) INTO THE MARIONETTE LINES AREA (OFF LABEL USE OF DEVICE). BATCH NUMBER WAS REPORTED AS A00117970 (EXPIRY DATE: 06/2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00117970 (EXPIRY DATE: 06/2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. A 27 G NEEDLE IN A RETROGRADE LINEAR THREAD FASHION WAS USED. RADIESSE(+) WAS INJECTED OVER 3 TO 4 LINEAR RETROGRADE THREADS. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A POTENTIAL VASCULAR OCCLUSION. IN THE EVENING, ON A DAY OF THE INJECTION, THE PATIENT CONTACTED THE REPORTER THAT WAS WONDERING IF ON THE INJECTION AREA WAS A BRUISE OR POTENTIAL VASCULAR OCCLUSION. IT WAS BELIEVED THAT WAS A BRUISE, HOWEVER, A FOLLOW-UP FOR THE PATIENT WAS SUGGESTED. AT THE TIME OF THIS REPORT, THE REPORTER BELIEVED THE TREATMENT OF OBSERVATION TO BE WHAT WAS NEEDED. MONITORING AND REASSESSING WAS ALSO PLANNED ON (B)(6) 2023. THE OUTCOME OF THE EVENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18398568 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE(+), ON (B)(6) 2023. IN 2023, AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED MAJOR SWELLING IN THE INJECTION AREA AND RANDOM PATCHES UP THE ARM. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 27-NOV-2023: THE CASE WAS UPGRADED TO SERIOUS. THE EVENT TERM PATCHES WAS CHANGED TO RASH/HIVES AND CODING WAS CHANGED FROM INJECTION SITE DISCOLORATION TO INJECTION SITE HIVES. THE EVENT MAJOR SWELLING WAS DELETED, IT WAS CONSIDERED TO BE A SYMPTOM OF HIVES. PATIENTS INITIALS, DATE OF BIRTH ((B)(6) ) AND WEIGHT (62.5 KG) WERE PROVIDED. SHE WAS 52 YEARS OLD AT THE TIME OF THE EVENT. SHE WAS INJECTED WITH 6 SYRINGES OF RADIESSE(+), INTO THE HANDS AND NASOLABIAL FOLDS. BATCH NUMBER WAS REPORTED AS A00085940 (EXPIRY DATE: 11/2024). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00085940 (EXPIRY DATE: 11/2024). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE REPORTED AS NONE. THE PATIENT HAD NO PRIOR AESTHETIC TREATMENT

  Patient problems: Urticaria

  MAUDE report 18257784 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2023-00109 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE, INTO THE NECK (OFF LABEL USE OF DEVICE). RADIESSE WAS HYPERDILUTED. AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED NECK NODULES. CORRECTIVE TREATMENT INCLUDED HYLENEX. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 10-OCT-2023: THE CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THE EVENTS PRODUCT PREPARATION ISSUE AND PRODUCT DISTRIBUTION ISSUE WERE ADDED. THE EVENT TERM NECK NODULES WAS AMENDED TO NODULES ON THE LEFT MEDIAL NECK AND SUBMENTAL. PATIENTS INITIALS, AGE, DATE OF BIRTH, GENDER (FEMALE) AND WEIGHT (ABOUT 74.8 KG) WERE PROVIDED. SHE WAS 56 YEARS OLD (AMBIGUOUSLY REPORTED AS 57 YEARS OLD) AT THE TIME OF THE EVENT. SHE WAS INJECTED WITH HYPERDILUTED (PRODUCT PREPARATION ISSUE) RADIESSE(+), ON (B)(6) 2023. BATCH NUMBER WAS REPORTED AS A00066940 (EXPIRY DATE: 07/2024). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00066940 (EXPIRY DATE: 07/

  Patient problems: Deposits

  MAUDE report 17959647 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2023-00110 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE, INTO THE NECK (OFF LABEL USE OF DEVICE). RADIESSE WAS HYPERDILUTED. AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED NECK NODULES. CORRECTIVE TREATMENT INCLUDED HYLENEX. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 10-OCT-2023: THE CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THE EVENTS PRODUCT PREPARATION ISSUE AND PRODUCT DISTRIBUTION ISSUE WERE ADDED. THE EVENT TERM NECK NODULES WAS AMENDED TO NODULES ON THE LEFT MEDIAL NECK AND SUBMENTAL. PATIENTS INITIALS, AGE, DATE OF BIRTH, GENDER (FEMALE) AND WEIGHT (ABOUT 74.8 KG) WERE PROVIDED. SHE WAS 56 YEARS OLD (AMBIGUOUSLY REPORTED AS 57 YEARS OLD) AT THE TIME OF THE EVENT. SHE WAS INJECTED WITH HYPERDILUTED (PRODUCT PREPARATION ISSUE) RADIESSE(+), ON (B)(6) 2023. BATCH NUMBER WAS REPORTED AS A00066940 (EXPIRY DATE: 07/2024). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00066940 (EXPIRY DATE: 07/

  Patient problems: Nodule

  MAUDE report 17958917 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS AN ADULT FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE(+), IN AN OFF LABEL WAY (AS REPORTED) INTO THE FACE. BATCH NUMBER WAS REPORTED AS A00087500 (EXPIRY DATE: 11/2024). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00087500 (EXPIRY DATE: 11/2024). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. RADIESSE(+) WAS DILUTED IN A 3:1 RATIO (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE), INJECTED USING A 22 G CANNULA. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION ON THE CHEEK. SHE HAD A SLOW CAPILLARY REFILL AND DISCOLORATION. THE REPORTER USED WARM COMPRESS, ASPIRIN AND MASSAGE, TO HELP BREAK IT UP. SHE WAS FOLLOWED UP NEXT DAY AND KEPT DOING WARM COMPRESS AND MASSAGE. ON THE NEXT DAY, IT LOOKED LIKE A HUGE BRUISE. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16844479 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2023-00039 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. THE PATIENTS INITIALS AND DATE OF BIRTH WERE REPORTED AS UNKNOWN. SHE WAS INJECTED WITH 3 SYRINGES OF RADIESSE(+), INTO SEVERAL AREAS. BATCH NUMBER WAS REPORTED AS A00061720 (EXPIRY DATE: 06/2024). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00061720 (EXPIRY DATE: 06/2024). RADIESSE(+) WAS HYPER DILUTED (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE). AS REPORTED, AN OFF LABEL TECHNIQUE WAS USED. THE PATIENT PREVIOUSLY USED RADIESSE(+) FOR YEARS, AND WAS EXPERIENCED WITH HYPER DILUTED RADIESSE (AS REPORTED). SHE NEVER HAD THAT PROBLEM BEFORE. THE PATIENTS MEDICAL HISTORY INCLUDED FINE LINES. AFTER THE TREATMENT WITH RADIESSE(+), THE PATIENT EXPERIENCED NO IMPROVEMENT AND THAT HER SKIN ALMOST LOOKED WORSE. SHE HAD LITTLE TO NO RESULT AND HER FINE LINES APPEARED WORSE. HER SKIN LOOKED VERY DEHYDRATED. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 28-MAR-2023: THIS CA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16707169 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2023-00040 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. THE PATIENTS INITIALS AND DATE OF BIRTH WERE REPORTED AS UNKNOWN. SHE WAS INJECTED WITH 3 SYRINGES OF RADIESSE(+), INTO SEVERAL AREAS. BATCH NUMBER WAS REPORTED AS A00061720 (EXPIRY DATE: 06/2024). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00061720 (EXPIRY DATE: 06/2024). RADIESSE(+) WAS HYPER DILUTED (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE). AS REPORTED, AN OFF LABEL TECHNIQUE WAS USED. THE PATIENT PREVIOUSLY USED RADIESSE(+) FOR YEARS, AND WAS EXPERIENCED WITH HYPER DILUTED RADIESSE (AS REPORTED). SHE NEVER HAD THAT PROBLEM BEFORE. THE PATIENTS MEDICAL HISTORY INCLUDED FINE LINES. AFTER THE TREATMENT WITH RADIESSE(+), THE PATIENT EXPERIENCED NO IMPROVEMENT AND THAT HER SKIN ALMOST LOOKED WORSE. SHE HAD LITTLE TO NO RESULT AND HER FINE LINES APPEARED WORSE. HER SKIN LOOKED VERY DEHYDRATED. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 28-MAR-2023: THIS CA

  Patient problems: Wrinkling

  MAUDE report 16707045 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED, WITH RADIESSE. ON (B)(6) 2022, AFTER THE TREATMENT WITH RADIESSE, THE PATIENT EXPERIENCED SEVERE NODULARITY ALONG THE NASOLABIAL FOLDS AND MARIONETTE LINES. AFTER 4 MONTHS THEY ELEVATED TO PERFORM INTRAORAL EXCISIONS OF THE INVOLVED TISSUE. THE PATIENT WAS VERY UPSET AS WERE THEY. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED. FOLLOW-UP INFORMATION WAS RECEIVED ON 24-MAR-2023: THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THE PATIENTS AGE, DATE OF BIRTH AND WEIGHT (68.03 KG) WERE PROVIDED. SHE WAS 69 YEARS OLD AT THE TIME OF THE EVENTS. SHE WAS INJECTED, WITH A TOTAL OF 3 ML RADIESSE(+), ON (B)(6) 2022. BATCH NUMBER WAS REPORTED AS A00083980 . A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00083980 (EXPIRY DATE: 10/2024). SHE HAD NO PREVIOUS FILLER TREATMENTS. THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. THE PATIENT HAD A WORSENING OF NODULARITY IN THE NASOLABIAL FOLDS AND MARIONETTE LI

  Patient problems: Nodule

  MAUDE report 16683566 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS LINKED TO LSSMV CASE NUMBERS (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US NURSE AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED, WITH A TOTAL OF 1.5 ML OF RADIESSE(+), INTO THE LATERAL ZYGOMATIC BONE/LATERAL CHEEKS (OFF LABEL USE OF DEVICE), ON (B)(6) 2022. THE PATIENT WAS INJECTED WITH 0.75 ML OF RADIESSE(+) ON EACH SIDE. THE PATIENTS MEDICAL HISTORY INCLUDED DEPRESSION, SARCOIDOSIS, AND ALLERGY TO PENICILLIN. CONCOMITANT MEDICATIONS INCLUDED TRINTELLIX (ONGOING), SEMAGLUTIDE (ONGOING). THE PATIENTS PAST MEDICATION INCLUDED "PENICILLIN". SHE WAS A ALERT AND ORIENTED TO PERSON, PLACE AND TIME (AAOX3) WITH NORMAL SPEECH, THOUGHTS KINETIC GAIT AND GROOMING. IN (B)(6) 2022, AFTER THE TREATMENT WITH RADIESSE(+), THE PATIENT EXPERIENCED MODERATE SWELLING FOR AROUND 5 TO 7 DAYS AFTER INJECTIONS. SHE WAS VERY TENDER ON BILATERAL CHEEKS FOR 2 WEEKS. EVERYTHING HEALED APPROPRIATELY AND SHE HAD NO MORE ISSUES. ON (B)(6) 2022, THE PATIENT WAS INJECTED WITH A TOTAL OF 0.6 ML OF REVANESSE LIPS INTO THE MARIONETTE LINES. ON THE SAME DAY, SHE WAS CONCOMITANTLY INJECTED WITH A TOTAL OF 1 ML OF BELOTERO BALANCE LIDOCAINE, INTO THE TEAR TROUGHS.

  Patient problems: Sinusitis

  MAUDE report 16675124 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INFORMATION WAS RECEIVED ON 28-MAR-2023: THE PATIENT WAS INJECTED, WITH APPROXIMATELY 0.2 ML OF RADIESSE(+), ON 22-FEB-2023. BATCH NUMBER WAS REPORTED AS A00041280 (EXPIRY DATE: 12/2023). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00041280 (EXPIRY DATE: 12/2023). THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON (B)(6) 2023, AFTER THE TREATMENT WITH RADIESSE(+), THE PATIENT EXPERIENCED A VASCULAR OCCLUSION. CORRECTIVE TREATMENT INCLUDED ASPIRIN, HYLENEX, SODIUM CHLORIDE, PREDNISONE 20 MG (FOR 3 DAYS) AND WARM COMPRESSES / MASSAGE. NO RELEVANT LABORATORY TESTS WERE PERFORMED. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVED, ON THE SAME DAY, ON (B)(6) 2022 (CHANGED FROM UNKNOWN). THE OUTCOME WAS REPORTED AS EXCELLENT, WITH NO RESIDUAL SYMPTOMS. IN THE OPINION OF THE REPORTER, THE EVENT WAS RELATED TO RADIESSE(+).

  Patient problems: Obstruction/Occlusion

  MAUDE report 16503805 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDRS 3013840437-2023-00012 AND 3013840437-2023-00013, REFERRING TO THE SAME PATIENT. FOLLOW-UP INFORMATION WAS RECEIVED ON 21-FEB-2023: THE EVENTS ACUTE ISCHEMIC STROKE OF THE LEFT FRONTAL CORTEX AND POSTERIOR ISCHEMIC OPTIC NEUROPATHY WERE DELETED, AS THE EVENTS WERE CONFIRMED BY THE PHYSICIAN AS SECONDARY TO THE REPORTED EVENT FILLER EMBOLISM. THE PATIENTS INITIALS, AGE, DATE OF BIRTH AND GENDER (FEMALE) WERE PROVIDED. SHE WAS 77 YEARS OLD AT THE TIME OF THE EVENT. HER WEIGHT WAS UNKNOWN. THE PATIENT WAS PREVIOUSLY TREATED WITH FILLERS, MULTIPLE TIMES. THE PATIENTS MEDICAL HISTORY (AND RISK FACTORS) INCLUDED CHRONIC SEVERE MIGRAINES, ARTHRITIS, HEARING LOSS AND A MALIGNANT TUMOR OF BREAST. CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON 01-FEB-2023, THE PATIENT EXPERIENCED THE ADVERSE EVENTS. THE VISION LOSS WAS CONFIRMED BY A RETINAL SPECIALIST, AND THE ACUTE ISCHEMIC STROKE WAS CONFIRMED BY AN MRI AND A NEUROLOGIST. CORRECTIVE TREATMENT INCLUDED HYALURONIDASE (600 UNITS), NITROPASTE 2%, ASPIRIN 325 MG, AND IBUPROFEN 600 MG. THE ACUTE ISCHEMIC STROKE WAS ACTUALLY LOCATED IN THE RIGHT FRONTAL CORTEX. THE PATIENT WAS EVALUATED BY A NEUROLOGIST, WHO FELT TH

  Patient problems: Foreign Body Embolism

  MAUDE report 16395821 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDRS 3013840437-2023-00012 AND 3013840437-2023-00014, REFERRING TO THE SAME PATIENT. FOLLOW-UP INFORMATION WAS RECEIVED ON 21-FEB-2023: THE EVENTS ACUTE ISCHEMIC STROKE OF THE LEFT FRONTAL CORTEX AND POSTERIOR ISCHEMIC OPTIC NEUROPATHY WERE DELETED, AS THE EVENTS WERE CONFIRMED BY THE PHYSICIAN AS SECONDARY TO THE REPORTED EVENT FILLER EMBOLISM. THE PATIENTS INITIALS, AGE, DATE OF BIRTH AND GENDER (FEMALE) WERE PROVIDED. SHE WAS 77 YEARS OLD AT THE TIME OF THE EVENT. HER WEIGHT WAS UNKNOWN. THE PATIENT WAS PREVIOUSLY TREATED WITH FILLERS, MULTIPLE TIMES. THE PATIENTS MEDICAL HISTORY (AND RISK FACTORS) INCLUDED CHRONIC SEVERE MIGRAINES, ARTHRITIS, HEARING LOSS AND A MALIGNANT TUMOR OF BREAST. CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON (B)(6) 2023, THE PATIENT EXPERIENCED THE ADVERSE EVENTS. THE VISION LOSS WAS CONFIRMED BY A RETINAL SPECIALIST, AND THE ACUTE ISCHEMIC STROKE WAS CONFIRMED BY AN MRI AND A NEUROLOGIST. CORRECTIVE TREATMENT INCLUDED HYALURONIDASE (600 UNITS), NITROPASTE 2%, ASPIRIN 325 MG, AND IBUPROFEN 600 MG. THE ACUTE ISCHEMIC STROKE WAS ACTUALLY LOCATED IN THE RIGHT FRONTAL CORTEX. THE PATIENT WAS EVALUATED BY A NEUROLOGIST, WHO FELT TH

  Patient problems: Eye Injury

  MAUDE report 16395764 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDRS 3013840437-2023-00013 AND 3013840437-2023-00014, REFERRING TO THE SAME PATIENT. FOLLOW-UP INFORMATION WAS RECEIVED ON 21-FEB-2023: THE EVENTS ACUTE ISCHEMIC STROKE OF THE LEFT FRONTAL CORTEX AND POSTERIOR ISCHEMIC OPTIC NEUROPATHY WERE DELETED, AS THE EVENTS WERE CONFIRMED BY THE PHYSICIAN AS SECONDARY TO THE REPORTED EVENT FILLER EMBOLISM. THE PATIENTS INITIALS, AGE, DATE OF BIRTH AND GENDER (FEMALE) WERE PROVIDED. SHE WAS 77 YEARS OLD AT THE TIME OF THE EVENT. HER WEIGHT WAS UNKNOWN. THE PATIENT WAS PREVIOUSLY TREATED WITH FILLERS, MULTIPLE TIMES. THE PATIENTS MEDICAL HISTORY (AND RISK FACTORS) INCLUDED CHRONIC SEVERE MIGRAINES, ARTHRITIS, HEARING LOSS AND A MALIGNANT TUMOR OF BREAST. CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON (B)(6) 2023, THE PATIENT EXPERIENCED THE ADVERSE EVENTS. THE VISION LOSS WAS CONFIRMED BY A RETINAL SPECIALIST, AND THE ACUTE ISCHEMIC STROKE WAS CONFIRMED BY AN MRI AND A NEUROLOGIST. CORRECTIVE TREATMENT INCLUDED HYALURONIDASE (600 UNITS), NITROPASTE 2%, ASPIRIN 325 MG, AND IBUPROFEN 600 MG. THE ACUTE ISCHEMIC STROKE WAS ACTUALLY LOCATED IN THE RIGHT FRONTAL CORTEX. THE PATIENT WAS EVALUATED BY A NEUROLOGIST, WHO FELT TH

  Patient problems: Stroke/CVA

  MAUDE report 16395720 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050052. One submission often covers many models, so check the product and lot details in each record.

• Z-2607-2016 · May 20, 2016 · Terminated
  Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of m
• Z-0145-2012 · Aug 18, 2011 · Terminated
  MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number
• Z-2221-2011 · Apr 6, 2011 · Terminated
  Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #