Radiesse (+) Lidocaine1.5cc Injectable Implant 8063M0K1Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M2138063M0K15), received between Apr 5, 2016 and Dec 18, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Off-Label Use” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 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 CASE WAS LINKED WITH CASE (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE(+). BATCH NUMBER WAS REPORTED AS A00119840 (EXPIRY DATE: 04-AUG-2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00119840 (EXPIRY DATE: 04-AUG-2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A BONY RESORPTION OF MANDIBLE, HAD A HOLE IN HER JAW. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 11-DEC-2025: THE LINKING SENTENCE WAS ADDED. THE PATIENT WAS INJECTED WITH A TOTAL OF 1 ML OF RADIESSE(+), INTO THE RETROGNATHIC CHIN (OFF LABEL USE OF DEVICE), ON (B)(6) 2024. RADIESSE(+) WAS INJECTED WITH A NEEDLE 0.5 ML WITH AN INFERIOR APPROACH SUPRAPERIOSTIUM (REPORTED AS SUPERPERIOSTIUM) FOR ANTERIOR PROJECTION. A TOTAL OF 1ML WAS INJECTED INTO THE SUPRAPERIOSTIUM (REPORTED AS SUPERPERIOSTIUM) ANTERIOR WITH SLIGHT ANGLE UP ON THE NEEDLE TO ELONGATE THE CHIN. RADIESSE(+) WAS NOT DILUTED. THE PATIENT WAS CONCOMITANTLY INJECTED SUBCU

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

  MAUDE report 23841375 ↗
• InjuryNov 21, 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 A US HEALTH CARE PROFESSIONAL AND CONCERNS A 49-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE(+) INTO THE CHEEK (OFF LABEL USE OF DEVICE) DOWN TO THE BONE. BATCH NUMBER WAS REPORTED AS A00133450 (EXPIRY DATE: 31-OCT-2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00133450 (EXPIRY DATE: 31-OCT-2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. TWO DAYS AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED MALAR EDEMA, EXTREME ITCHINESS, THAT THE AREA WAS FIRM TO TOUCH, PAIN AND INFLAMMATION. TWO-PITTED EDEMA WAS ON THE LEFT SIDE ONLY. SHE HAD EXTREME ITCHINESS, BUT WITH NO PAIN ASSOCIATED. THE PATIENT WAS TREATED WITH 40 MG OF PREDNISONE AND 2 DOSES OF DOXYCYCLINE. THE SWELLING WORSENED, THE AREA WAS STILL ITCHY AND SHE WAS SUFFERING PAIN FROM INFLAMMATION. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT INFLAMMATION WAS CONSIDERED AS NOT RESOLVED. THE OUTCOME OF THE EVENT FIRM TO TOUCH WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 30-JUL-2025: THE PATIENT WAS INJECTED WITH A TOTAL OF 3 ML OF RADIESSE(+) INTO BOTH CHEEKS. RADI

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

  MAUDE report 23617560 ↗
• InjuryMay 8, 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 CONSUMER REPORT WAS RECEIVED FROM A US CONSUMER AND CONCERNS AN ADULT FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE (+) INTO HER LIPS (OFF LABEL USE OF DEVICE), ON (B)(6) 2025. BATCH NUMBER WAS REPORTED AS A00133450 (EXPIRY DATE: 10/2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE (+) WAS CONFIRMED AS A00133450 (EXPIRY DATE: 10/2025). A LOT SEARCHE IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. RADIESSE (+) WAS INJECTED INSTEAD OF A HYALURONIC ACID (REPORTED AS HA) FILLER. THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA AND AUTOIMMUNE DISEASES. IN 2025, AFTER THE RADIESSE (+) INJECTION, THE PATIENT EXPERIENCED ENORMOUS, PAINFUL CALCIUM DEPOSITS/LUMPS IN HER LIPS. THE PLASTIC SURGEON TRIED TO CUT THE PATIENTS LIPS OPEN AND REMOVE THE FILLER, BUT WAS NOT ABLE TO DO IT WITHOUT RUINING THE PATIENTS LIPS. THE PATIENTS LIPS WERE BLUE THROUGHOUT, WITH POSSIBLE COMPROMISED CIRCULATION. A CORRECTIVE TREATMENT WITH THIOSULFATE WAS CONSIDERED. A SAMPLE OF THE FILLER WAS SENT TO PATHOLOGY, AND RADIESSE(+) WAS CONFIRMED. THE PATIENT WANTED TO GET TREATMENT OPTIONS AND WAS CONCERNED ABOUT LONG TERM SIDE EFFECTS OF HAVING RADIESSE(+) IN HER LIPS, ESP

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

  MAUDE report 21985329 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS LINKED TO LSSMV CASE NUMBER: (B)(4), REFERRING TO THE SAME REPORTER. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US NURSE AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE. THE PATIENT HAD A CHEMICAL PEEL. FOUR WEEKS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED NODULES. AS REPORTED, THE PATIENT HAD PRIOR TO THE EVENT A CHEMICAL PEEL. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 24-MAY-2023: LINKING SENTENCE WAS ADDED AT THE TOP OF THE NARRATIVE. THE CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US NURSE AND CONCERNS A 65-YEAR-OLD FEMALE PATIENT (WEIGHT: ABOUT 52.16 KG). SHE WAS INJECTED WITH 1.5 ML (ALSO REPORTED AS 1 SYRINGE) OF RADIESSE(+), INTO THE CHEEKS (OFF LABEL USE OF DEVICE) AND NASOLABIAL FOLDS, ON (B)(6) 2023. BATCH NUMBER WAS REPORTED AS A00065480 (EXPIRY DATE: 07/2024). 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 A00065480 (EXPIRY DATE: 07/2024). ON (B)(6)2023, ALSO REPORTED AS 5.5 WEEKS AFTER THE INJECTION WITH RA

  Patient problems: Nodule

  MAUDE report 17166711 ↗
• InjuryAug 12, 2021Adverse 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 FEMALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE®, INTO THE LEFT CHEEK (OFF LABEL USE OF DEVICE). AFTER THE TREATMENT WITH RADIESSE®, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 06-AUG-2021: THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE® TO RADIESSE(+)®. THE PATIENTS INITIALS, DATE OF BIRTH (REPORTED AS (B)(6)), AGE AND WEIGHT ((B)(6) KG) WERE PROVIDED. SHE WAS (B)(6) YEARS OLD AT THE TIME OF THE EVENT. IT WAS CONFIRMED THAT THE PATIENT WAS INJECTED WITH A TOTAL OF 3 ML (1.5 INTO EACH SIDE) OF RADIESSE(+)®, INTO THE CHEEKS, ON (B)(6) 2021. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+)® WAS CONFIRMED AS 100124384 (EXPIRY DATE 10/2021). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE PATIENT WAS NOT PREVIOUSLY TREATED WITH FILLERS. THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON (B)(6) 2021, DURING THE TREATMENT WITH RADIESSE(+)® ON HER LEFT SIDE, THE PATIENT EXPERIENCED BLANCHING. IT WAS A 0.2 ML INJECTION POINT LOCATED ON THE MALAR GROVE. B

  Patient problems: Obstruction/Occlusion

  MAUDE report 12313258 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INFORMATION WAS RECEIVED ON 20-OCT-2020: THE EVENTS RADIESSE MIGHT BE IN THE VESSEL, NODULE AND BRUISE WERE ADDED. IT WAS CONFIRMED THAT THE PATIENT WAS INJECTED WITH RADIESSE(+)®, ON (B)(6) 2020. ON (B)(6) 2020, THE DAY OF THE RADIESSE(+)® INJECTION, THE PATIENT EXPERIENCED THE ALLERGY TO RADIESSE(+)®, FURTHER DESCRIBED AS AN ANAPHYLACTIC TYPE RESPONSE. ON 20-OCT-2020, THE DAY OF THIS REPORT, THE REPORTER SAW THE PATIENT AND WAS CONCERNED THAT RADIESSE(+)® MIGHT BE IN THE VESSEL. THE PATIENT HAD A NODULE AND A BRUISE. THE OUTCOME OF THE EVENTS RADIESSE MIGHT BE IN THE VESSEL, NODULE AND BRUISE WAS UNKNOWN. THE OUTCOME OF THE EVENTS ALLERGY TO RADIESSE/ ANAPHYLACTIC TYPE RESPONSE AND PRODUCT PREPARATION ISSUE REMAINED UNCHANGED. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2020: THE EVENT RADIESSE MIGHT BE IN THE VESSEL WAS DELETED. THE EVENT TERM ALLERGY TO RADIESSE / ANAPHYLACTIC TYPE RESPONSE WAS AMENDED TO ALLERGY TO RADIESSE /ANAPHYLACTIC TYPE RESPONSE / SERUM SICKNESS FROM THE BEE STINGS, AND THE CODING REMAINED UNCHANGED. THE EVENTS SWELLING, PRODUCT MIGRATION AND OFF LABEL USE OF DEVICE WERE ADDED. THE INITIAL NARRATIVE WAS AMENDED, THE SENTENCE A TOTAL OF 1.5 ML

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 10718652 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN'S ASSISTANT (PA) VIA MERZ CUSTOMER SOLUTIONS CONCERNING A (B)(6) YEAR OLD FEMALE PATIENT WHO RECEIVED RADIESSE(+). RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2019, THE PATIENT WAS INJECTED WITH AN UNSPECIFIED AMOUNT OF RADIESSE(+) IN THE CHEEKS. ON AN UNSPECIFIED DATE POST INJECTION, THE PATIENT EXPERIENCED POST INFLAMMATORY, HARD TO PALPATE NODULES. THE PATIENT WAS TREATED WITH DOXYCYCLINE AND PREDNISONE. THE NODULES RESOLVED ON AN UNSPECIFIED DATE DURING TREATMENT WITH PREDNISONE. HOWEVER, WHEN TREATMENT WITH PREDNISONE WAS STOPPED, THE NODULES RETURNED. CAUSALITY WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 24 SEPTEMBER 2019 FROM THE REPORTER: THE PATIENT HAD NO KNOWN DRUG ALLERGIES (NKDA) AND NO HISTORY OF MEDICAL ILLNESSES. THERE WERE NO RELEVANT CONCOMITANT MEDICATIONS. THE PATIENT WAS INJECTED WITH 2 SYRINGES, 3ML, OF RADIESSE(+). ON (B)(6) 2019 THE PATIENT EXPERIENCED MODERATE SWELLING TO THE AREA OF INJECTION ONE (1) MONTH AFTER INJECTION WHICH, WHEN PALPATED, WAS FIRM AND TENDER. THE PATIENT WAS SEEN BY AN EAR, NOSE AND THROAT (ENT) AT WHICH TIME A COMPUTED TOMOGRAPHY (CT) S

  Patient problems: No Code Available

  MAUDE report 9131570 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A REGISTERED NURSE AND CONCERNS A (B)(6) FEMALE PATIENT WHO WAS INJECTED WITH 1.5CC OF RADIESSE(+) TO AN UNSPECIFIED SITE ON AN UNSPECIFIED DATE. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS REPORTED AS NONE. WITHIN TWO HOURS OF INJECTION, THE PATIENT EXPERIENCED AN ALLERGIC REACTION, CLARIFIED AS SWELLING, REDNESS, PAIN, TENDERNESS, FACIAL EDEMA, DIFFICULTY BREATHING AND DIFFICULTY SWALLOWING. TREATMENT REPORTED AS PREDNISONE AND TRIAMCINOLONE INJECTIONS INTRAMUSCULARLY. CAUSALITY REPORTED AS RELATED. LOT NUMBER REPORTED AS 100107455. OUTCOME REPORTED AS HEALED IN FIVE DAYS.

  Patient problems: Respiratory Distress

  MAUDE report 8248502 ↗
• InjuryFeb 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN ASSISTANT REPORTED THAT A (B)(6) FEMALE WAS TREATED WITH RADIESSE (+) INJECTABLE IMPLANT. THIS WAS THE PATIENT'S FIRST TIME USING THE PRODUCT. ON AN UNKNOWN DATE, THE PATIENT WAS INJECTED WITH AN UNKNOWN AMOUNT OF RADIESSE (+) IN UNSPECIFIED SITE(S). AN UNKNOWN TIME POST INJECTION, THE PATIENT EXPERIENCED FACE SWELLING, SWELLING IN CHEEKS, AROUND EYES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN ASSISTANT ON (B)(6) 2018: ON (B)(6) 2018, THE PATIENT WAS INJECTED WITH 1.5 CC RADIESSE (+) TO THE MIDFACE REGION. THE FACE HAD BEEN CLEANED PRIOR WITH HIBICLENS AND ARNICA WAS APPLIED AFTER TREATMENT. SHORTLY AFTER TREATMENT, THE PATIENT BEGAN TO HAVE GENERALIZED FACIAL EDEMA TO THE POINT HER EYES WERE NEARLY CLOSED. THE PATIENT WAS TREATED AT THE EMERGENCY ROOM (ER) WITH SOLUMEDROL AND WAS PRESCRIBED A MEDROL DOSE PACK ALONG WITH COLD COMPRESSES. AS OF (B)(6) 2018, THE SWELLING HAS IMPROVED APPROXIMATELY 50%. THIS WAS THE FIRST TIME THE PATIENT HAS BEEN INJECTED WITH DERMAL FILLER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN ASSISTANT ON 31-JAN-2018: THE PATIENT HAD A HISTORY OF ALLERGIC REACTION TO IBUPROFEN AND CORTISONE INJECTIONS. CONCOMITANT MEDICATI

  Patient problems: Edema

  MAUDE report 7237005 ↗
• InjuryMay 17, 2016Patient-Device Incompatibility

  ON (B)(6) 2016, A (B)(6) FEMALE PATIENT WAS INJECTED WITH ONE 1.5CC SYRINGE OF RADIESSE+ TO THE NASOLABIAL FOLDS AND 40 UNITS OF BOTOX TO AN UNKNOWN AREA. ON THE NIGHT OF (B)(6) 2016, THE PATIENT FELT MORE PAIN AND SWELLING THAN NORMAL IN THE INJECTED AREAS. SHE APPLIED ICE. WITHIN ONE TO TWO DAYS, PATIENT PRESENTED TO A WALK-IN CLINIC. SHE WAS TOLD SHE MAY HAVE ICED THE AREA TOO MUCH, CAUSING FROST BITE. SHE WAS REFERRED BACK TO HER INJECTOR AND WAS SEEN ON (B)(6) 2016. PATIENT WAS DIAGNOSED WITH IMPETIGO AND CELLULITIS AND STARTED ON KEFLEX AND BACTROBAN. THE AFFECTED AREA INVOLVED THE LEFT NASOLABIAL FOLD, EXTENDING ABOUT THREE INCHES ALONG THE FOLD, UP THE SIDE OF THE NOSE AND TO THE TIP EDGE OF THE NOSE. REPORTER DESCRIBED THE SKIN AS BLACK AND DEAD. PATIENT WAS REFERRED TO A DERMATOLOGIST, WHO SUGGESTED PATIENT SEE A PLASTIC SURGEON. THE PATIENT STARTED HYPERBARIC OXYGEN TREATMENTS ON AN UNKNOWN DATE AND HAS HAD TWO TREATMENTS. SHE WAS SEEN IN FOLLOW-UP APPOINTMENTS WITH INJECTOR ON (B)(6) 2016. ON (B)(6) 2016, INJECTOR PROVIDED PATIENT WITH SAMPLES OF CIALIS 5MG TO TAKE ONCE DAILY. AS OF PATIENT'S LAST FOLLOW UP VISIT WITH INJECTOR, SHE WAS DOING MUCH BETTER. SHE WAS HEALING

  Patient problems: Cellulitis; Necrosis; Pain; Skin Discoloration; Swelling

  MAUDE report 5659398 ↗
• InjuryApr 14, 2016Patient-Device Incompatibility

  OFFICE MANAGER FOR PHYSICIAN'S OFFICE REPORTED VIA A SALES REPRESENTATIVE THAT A (B)(6) FEMALE PATIENT RECEIVED RADIESSE+ IN THE NASOLABIAL FOLDS (NLF). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. PATIENT HAS NO KNOWN ALLERGIES. PATIENT WAS INJECTED WITH RADIESSE (MIX KIT) TO THE MIDFACE IN (B)(6) 2015 WITHOUT PROBLEMS. ON (B)(6) 2016, PATIENT WAS INJECTED WITH 1/2 SYRINGE OF RADIESSE+ TO THE NLF. ONE HOUR POST INJECTION, PATIENT DEVELOPED SEVERE SWELLING AND WAS EVALUATED BY THE PHYSICIAN. PATIENT WAS SENT TO THE EMERGENCY ROOM ON (B)(6) 2016 AND TREATED WITH ORAL AND INTRAVENOUS (IV) CORTICOSTEROID. ON (B)(6) 2016, PATIENT WAS STABLE AND IMPROVING. ON (B)(6) 2016, ADDITIONAL INFORMATION WAS RECEIVED FROM THE OFFICE MANAGER. POST INJECTION, PATIENT HAD A LITTLE REDNESS TO NLF BUT OTHERWISE LOOKED FINE. FOUR HOURS POST INJECTION, PATIENT DEVELOPED SWELLING AROUND HER MOUTH, WORSE IN UPPER LIP. PATIENT'S UPPER LIP SPLIT DUE TO THE SWELLING. ON (B)(6) 2016, SHE WENT TO THE EMERGENCY ROOM, WHERE SHE RECEIVED AN UNKNOWN IV MEDICATION AND WAS SENT HOME WITH A 5-7 DAY COURSE OF PREDNISONE. SHE WAS NOT ADMITTED. PATIENT NOTED NOTHING UNUSUAL OR PROBLEMATIC AT TIME O

  Patient problems: Hypersensitivity/Allergic reaction; Swelling; Weakness

  MAUDE report 5576377 ↗
• InjuryApr 5, 2016Insufficient Device Problem Information

  A PHYSICIAN REPORTED VIA A SALES REPRESENTATIVE THAT A (B)(6) FEMALE RECEIVED RADIESSE+ IN HER HANDS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN WAS UNCERTAIN OF THE PATIENT'S PRIOR HISTORY OF FILLERS. ON (B)(6) 2016, THE PATIENT WAS INJECTED WITH TWO, 1.5 CC SIZED, SYRINGES OF RADIESSE+, ONE SYRINGE INTO EACH HAND. THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED CELLULITIS IN THE RIGHT HAND. THE PATIENT WAS PLACED ON UNSPECIFIED ORAL ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 8-MAR-2016: THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED EDEMA AND ERYTHEMA IN HER RIGHT HAND. EDEMA DID NOT APPEAR UNTIL APPROXIMATELY 12 DAYS POST INJECTION. THE PHYSICIAN WAS CURRENTLY TREATING THE PATIENT WITH KEFLEX (CEPHALEXIN) WITHOUT IMPROVEMENT. NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Cellulitis; Edema; Erythema

  MAUDE report 5547024 ↗

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 #