JUVEDERM ULTRA PLUS XC 94155Recalls & reported problems

Summary

The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 10888628000117), received between Jan 26, 2015 and Sep 14, 2026 — classified as 175 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (48 reports).

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 319 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inflammation

  MAUDE report 50765390 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA CLINICAL STUDY INJECTING A PATIENT WITH 0.7ML RIGHT TEMPLE, 0.7ML LEFT TEMPLE, 1.3ML RIGHT CHEEK, 1.3ML LEFT CHEEK, 2.0ML CHIN USING JUVÉDERM® VOLUMA® XC, 1ML RIGHT JAWLINE, 2ML LEFT JAWLINE USING JUVÉDERM® VOLUX¿ XC, 0.7ML RIGHT NASOLABIAL FOLD, 0.7ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC, AND 1ML RIGHT CHEEK, 1ML LEFT CHEEK USING SKINVIVE¿ BY JUVÉDERM®. ONE MONTH LATER, PATIENT WAS INJECTED WITH 1ML RIGHT TEMPLE, 1ML LEFT TEMPLE, 1.4ML RIGHT MID-FACE, 2ML LEFT MID-FACE USING JUVÉDERM® VOLUMA® XC AND 1.2ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC. THREE WEEKS LATER, PATIENT DEVELOPED NON-DEVICE RELATED URTICARIA AND ECZEMA IN THE RIGHT POSTERIOR JAWLINE NEAR THE JUVÉDERM® VOLUX¿ XC INJECTION SITE. TEN DAYS LATER, PATIENT WAS TREATED WITH CLARITIN 10MG, PEPCID 1 TABLET, HYDROCORTISONE CREAM 1%. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. APPROXIMATELY THREE WEEKS LATER, PATIENT EXPERIENCED "SUDDEN, NEW ONSET URINARY INCONTINENCE [NOT DEVICE RELATED] AND PRESENTED TO THE EMERGENCY DEPARTMENT". PATIENT WAS IN A CAR ACCIDENT 6 YEARS PRIOR WHERE THEY EXPERIENCED A L4-L5 DISC SLIP. TREATMENT WAS NOT REQUIRED

  Patient problems: Urinary Incontinence

  MAUDE report 24865858 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA CLINICAL STUDY INJECTING A PATIENT WITH 0.7ML RIGHT TEMPLE, 0.7ML LEFT TEMPLE, 1.3ML RIGHT CHEEK, 1.3ML LEFT CHEEK, 2.0ML CHIN USING JUVÉDERM® VOLUMA® XC, 1ML RIGHT JAWLINE, 2ML LEFT JAWLINE USING JUVÉDERM® VOLUX¿ XC, 0.7ML RIGHT NASOLABIAL FOLD, 0.7ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC, AND 1ML RIGHT CHEEK, 1ML LEFT CHEEK USING SKINVIVE¿ BY JUVÉDERM®. ONE MONTH LATER, PATIENT WAS INJECTED WITH 1ML RIGHT TEMPLE, 1ML LEFT TEMPLE, 1.4ML RIGHT MID-FACE, 2ML LEFT MID-FACE USING JUVÉDERM® VOLUMA® XC AND 1.2ML LEFT NASOLABIAL FOLD USING JUVÉDERM® ULTRA PLUS XC. THREE WEEKS LATER, PATIENT DEVELOPED NON DEVICE RELATED URTICARIA AND ECZEMA IN THE RIGHT POSTERIOR JAWLINE NEAR THE JUVÉDERM® VOLUX¿ XC INJECTION SITE. TEN DAYS LATER, PATIENT WAS TREATED WITH CLARITIN 10MG, PEPCID 1 TABLET, HYDROCORTISONE CREAM 1%. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. APPROXIMATELY THREE WEEKS LATER, PATIENT EXPERIENCED "SUDDEN, NEW ONSET URINARY INCONTINENCE [NOT DEVICE RELATED] AND PRESENTED TO THE EMERGENCY DEPARTMENT". PATIENT WAS IN A CAR ACCIDENT 6 YEARS PRIOR WHERE THEY EXPERIENCED A L4-L5 DISC SLIP. TREATMENT WAS NOT REQUIRED

  Patient problems: Urinary Incontinence

  MAUDE report 24865840 ↗
• InjuryMar 16, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE LIPS AND 0.2CC IN THE CHIN WITH JUVÉDERM® ULTRA PLUS XC. PATIENT EXPERIENCED A VASCULAR OCCLUSION "INTRAORALLY UNDER [THE] TONGUE". HCP NOTED THEY CHECKED ASPIRATION PRIOR TO EACH INJECTION. SYMPTOMS ARE ONGOING.

  Patient problems: Necrosis; Obstruction/Occlusion

  MAUDE report 24611493 ↗
• InjuryNov 14, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED PATIENT WAS TREATED WITH A TOPICAL RETINOID. PATIENT RECEIVED A V-BEAM TREATMENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23560747 ↗
• InjuryJul 9, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 1ML OF JUVÉDERM® ULTRA PLUS XC IN THE NASOLABIAL FOLD, PYRIFORM, AND LOWER CHEEK. HCP NOTICED THE PATIENT WAS EXPERIENCING VASCULAR OCCLUSION, "PALENESS AND BLANCHING OF SKIN AND STOPPED INJECTING". HCP TREATED THE PATIENT WITH 4ML OF HYALURONIDASE, MASSAGED THE SKIN, AND APPLIED HEAT. SYMPTOMS ARE ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22459816 ↗
• InjuryJun 23, 2025Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT INJECTED IN TEMPLES WITH 1ML PER SIDE JUVÉDERM® ULTRA PLUS XC AND IS STILL EXPERIENCING "SOME PAIN AND HAS SOME RESIDUAL FILLER", "HEADACHE ". TREATMENT INCLUDED TYLENOL , IBUPROFEN , DEXAMETHASONE, HYLENEX , GABAPENTIN , WARM COMPRESS, TOPICAL LIDO FOR PAIN RELIEF. ADDITIONALLY, PATIENT INFORMS THAT THE PAIN INS IMPACTING ITS QUALITY OF LIFE. SYMPTOMS NOT RESOLVED.

  Patient problems: Pain

  MAUDE report 22310095 ↗
• InjuryJun 7, 2025Off-Label Use; Off-Label Use

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, JUVÉDERM® VOLUX¿ XC IN THE JAWLINE, AND JUVÉDERM® ULTRA XC IN THE NLF. A FEW MONTHS LATER THE PATIENT COMPLAINED OF PAIN AND WANTED FILLER DISSOLVED. THE HCP DISSOLVED THE FILLER WITH HYLENEX AND SCHEDULED A FOLLOW-UP ON THE NEXT DAY FOR THE PATIENT TO GET AN MRI. THE RESULTS OF THE MRI WERE NO SIGNIFICANT FINDINGS. A FEW WEEKS LATER THE PATIENT WENT TO A NEUROLOGIST, AND THEY DID NOT RECOMMEND ANY MORE HYLENEX DUE TO NERVE DAMAGE. THE PATIENT CONTINUED TO COMPLAIN ABOUT PAIN AND HOW IT HAS BEEN IMPACTING THEIR QUALITY OF LIFE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS UNEXPECTED ADVERSE DRUG EXPERIENCE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162857 ↗
• InjuryJun 7, 2025Off-Label Use; Off-Label Use

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC IN THE TEMPLE, JUVÉDERM® VOLUX¿ XC IN THE JAWLINE, AND JUVÉDERM® ULTRA XC IN THE NLF. A FEW MONTHS LATER THE PATIENT COMPLAINED OF PAIN AND WANTED FILLER DISSOLVED. THE HCP DISSOLVED THE FILLER WITH HYLENEX AND SCHEDULED A FOLLOW-UP ON THE NEXT DAY FOR THE PATIENT TO GET AN MRI. THE RESULTS OF THE MRI WERE NO SIGNIFICANT FINDINGS. A FEW WEEKS LATER THE PATIENT WENT TO A NEUROLOGIST, AND THEY DID NOT RECOMMEND ANY MORE HYLENEX DUE TO NERVE DAMAGE. THE PATIENT CONTINUED TO COMPLAIN ABOUT PAIN AND HOW IT HAS BEEN IMPACTING THEIR QUALITY OF LIFE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS INJURY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) ((B)(4)) AND (B)(6) ((B)(4)). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 22162835 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED BEING INJECTED IN THE CHEEKS WITH 2CC OF JUVÉDERM® ULTRA PLUS XC. SIX DAYS LATER, THE PATIENTS "LEFT SIDE SALIVARY GLANDS BEGAN TO HURT, PAIN, SWOLLEN AND RIGHT-SIDE DENT [IN THE CHEEKS]". PATIENT REPORTED THEY HAVE BEEN PRESCRIBED ANTIBIOTICS BY URGENT CARE. INJECTING PHYSICIAN LATER REPORTED "PATIENT HAD A COINCIDENTAL PAROTITIS. THE INJECTION SITE WAS ABOUT 4-5 INCHES AWAY FROM THE SWELLING" AND STATED THE EVENT IS NOT DEVICE RELATED. SYMPTOMS RESOLVED ON AN UNKNOWN DATE.

  Patient problems: Salivary Gland Problem

  MAUDE report 21865456 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED WITH 1 CC OF JUVÉDERM® ULTRA PLUS XC IN THE MARIONETTE LINES AND WITH 6 SYRINGES OF JUVÉDERM® VOLUMA¿ XC IN THE CHEEKS/MIDFACE. THREE DAYS LATER, THE PATIENT EXPERIENCED AN ¿INFECTION¿ AND ¿REDNESS¿ ON THE CHIN, NEAR AN EXISTING CHIN IMPLANT. PRE TREATMENT INCLUDES CLEANING INJECTION WITH CHLORHEXIDINE. TWO DAYS LATER, THE PATIENT WAS TREATED WITH 210 UNITS OF HYLENEX. SYMPTOMS STATUS IS UNKNOWN. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER ABBVIE COMPLAINT (B)(6); (EMDR-76177). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM ULTRA PLUS XC.

  Patient problems: Unspecified Infection

  MAUDE report 21637660 ↗
• InjuryNov 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN THE LIPS WITH 1ML OF JUVÉDERM® ULTRA XC, IN THE LIPS WITH ONE SYRINGE JUVÉDERM® ULTRA PLUS XC. APPROXIMATELY TWO MONTHS LATER, PATIENT EXPERIENCED ¿LUMP AND SWELLING" ON THE UPPER LEFT-SIDE LIP WITH "DISCOMFORT, AND BURNING" IN THE LIPS AND HCP TREATED THE PATIENT WITH .01MLS OF HYLENEX®. APPROXIMATELY NINE MONTHS LATER, PATIENT WAS INJECTED WITH 0.5 ML IN LIPS AND 0.5ML IN CHEEKS OF JUVÉDERM® ULTRA XC. THE PATIENT EXPERIENCED CENTRAL AREA OF "SLIGHT INFLAMMATION AND BRUISING¿. ON UNSPECIFIC TIME LATER, PATIENT WAS INJECTED IN THE LIPS WITH 0.25ML OF AN UNKNOWN JUVÉDERM PRODUCT. THE PATIENT EXPERIENCED ¿SMALL BUMP, PUSTULE, AND ULCERATION" TO THE UPPER LIP. EVENTS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00884 (ABBVIE COMPLAINT (B)(4), MDR ID# 3005113652-2023-00886 (ABBVIE COMPLAINT (B)(4), MDR ID# 3005113652-2023-00885 (ABBVIE COMPLAINT (B)(4). THIS MDR IS BEING SUBMITTED FOR THE 2ND SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Abscess; Nodule

  MAUDE report 18117193 ↗
• InjuryJul 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED IN THE LIPS WITH JUVÉDERM® ULTRA PLUS XC. A ¿LIP OCCLUSION¿ IN THE LOWER RIGHT SIDE OCCURRED. PATIENT WAS TREATED WITH 1500 UNITS OF HYALURONIDASE WERE PROVIDED 2 HOURS APART, TOTAL 300 UNITS. ¿BRUISING AND OCCLUSION¿ RESOLVED AFTER 24 HOURS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17415728 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED IN LIPS, PIRIFORM APERTURE MARIONETTE LINES. 1 DAY LATER, PATIENT WAS SEEN IN ER DUE TO A STROKE AND L HAND WEAKNESS FEET TINGLING ARM/LEGS. MRI RESULT WITH RESULTS OF TLA.

  Patient problems: Stroke/CVA

  MAUDE report 17326321 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED AROUND THE MOUTH WITH 2 SYRINGES OF JUVÉDERM® ULTRA PLUS XC. UNSPECIFIC TIME LATER, PATIENT EXPERIENCED ¿RACING HEART AND HIGH BLOOD PRESSURE,¿ DEEMED NOT DEVICE RELATED. SYMPTOMS STATUS ARE UNKNOWN.

  Patient problems: High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 17318633 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED WITH ONE SYRINGE OF JUVÉDERM® ULTRA PLUS XC IN THE CHIN AND JAW AND INJECTED TWO SYRINGES OF JUVÉDERM VOLUMA® XC IN THE CHEEKS. THE PATIENT WAS ALSO CONCOMITANTLY INJECTED WITH BOTOX®. THE NEXT DAY THE PATIENT EXPERIENCED JAW PAIN. THREE DAYS LATER, PATIENT WENT TO THE ER FOR PAIN AND WAS TREATED WITH ANTIBIOTICS AND PAIN MEDICINE. THE NEXT DAY THE PATIENT STARTED EXPERIENCING SWELLING IN THE JAW AND WENT TO THE ER AGAIN AND WAS DIAGNOSED WITH CELLULITIS. THE SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# (B)(4) (ALLERGAN COMPLAINT #PR (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Cellulitis

  MAUDE report 17290042 ↗
• InjuryMar 31, 2023Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH ONE SYRINGE OF JUVÉDERM® ULTRA PLUS XC AND BOTOX IN THE GLABELLAR LINES. THREE DAYS LATER, PATIENT CONTACTED THE HEALTHCARE PROFESSIONAL WITH PHOTOGRAPHS. THE HEALTHCARE PROFESSIONAL OBSERVED SIGNS OF NECROSIS AND RECOMMENDED THAT THE PATIENT GO TO THE EMERGENCY ROOM. THE PATIENT WAS TREATED IN THE ER WITH ANTIBIOTICS AND HYLENEX. THE SYRINGE HAS BEEN DISCARDED AND THE CURRENT STATUS OF THE SYMPTOMS IS UNKNOWN.

  Patient problems: Necrosis

  MAUDE report 16659282 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED ALONG ZYGOMA BILATERALLY WITH 1ML OF JUVÉDERM VOLUMA® XC, AND IN THE BILATERAL NASOLABIAL FOLDS AND MARIONETTE LINES WITH 1ML JUVÉDERM® ULTRA PLUS XC AND IN LIP VERMILLION, PERIORAL AND FINE LINES IN ORAL COMMISSURES AND MARIONETTE LINE AREA WITH 1ML JUVÉDERM VOLBELLA® XC. APPROXIMATELY TWO MONTHS POST INJECTIONS THE PATIENT WAS DIAGNOSED WITH COVID-19. ABOUT TWO MONTHS AFTER THE PATIENT ¿BEGAN TO EXPERIENCE SENSITIVITY IN RIGHT UPPER LIP.¿ PATIENT THOUGHT THEY MIGHT BE DEVELOPING A COLD SORE, BUT NO OUTWARD SORE LESION APPEARED, BUT LIPS BECAME PROGRESSIVELY LUMPY AND SORE. TWO WEEKS LATER THE PATIENT CALLED THE OFFICE TO REPORT THEY WERE EXPERIENCING, ¿LIP SWELLING, SORENESS, WITH HARD BUMPS¿. THE SAME DAY THE PATIENT WAS SEEN IN THE OFFICE AND HCP NOTICED, ¿DIFFUSE EDEMA INVOLVING LIPS/CHEEKS. DISTINCT AREAS OF ERYTHEMA/INDURATION OF: RIGHT UPPER LIP INVOLVING VERMILLION AND PERIORAL LIP, MIDDLE AND LOWER LIP, RIGHT MARIONETTE LINE AREA. MULTIPLE NODULES. REPORTS MILD DISCOMFORT TO PALPATION. MILD TENDERNESS TO FIRM PALPATION OF BILATERAL ZYGOMAS BUT NO DISCERNABLE AREAS OF SWELLING/NODULES/OVERLYING SKIN CHANGES. THE

  Patient problems: Nodule

  MAUDE report 16475195 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 0.8CC AN UNSPECIFIED JUVÉDERM® ULTRA PLUS X. THE PATIENT WAS ALSO INJECTED CONCOMITANTLY WITH ¿IPL, AND BOTOX®¿. THE PATIENT EXPERIENCED A ¿VASOVAGAL REACTION¿ DURING THE INJECTION SERVICES. PATIENT LEFT THE CLINIC AFTER AN HOUR FEELING BETTER. TWO WEEKS LATER, THE PATIENT EXPERIENCED ¿VERTIGO¿. THE PATIENT ALSO EXPERIENCED A ¿BLACK SPOT IN THEIR VISION¿. SYMPTOMS ARE ONGOING.

  Patient problems: Visual Disturbances

  MAUDE report 16417516 ↗
• InjuryDec 1, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 0.8 ML IN THE SMILE LINES AND 0.2 ML IN THE MARIONETTE LINES OF JUVÉDERM® ULTRA PLUS XC. 12 HOURS LATER, PATIENT EXPERIENCED ¿VASCULAR OCCLUSION PRESENTING WITH MOTTLED PATTERN AND RETICULATED PIGMENTATION.¿ THE NEXT DAY, THE PATIENT WAS TREATED WITH ASPIRIN 81 MG PO AND HYALURONIDASE 300 U. PATIENT ALSO WAS TREATED WITH 243 MG OF ASPIRIN, 1 DAILY FOR A WEEK. SYMPTOMS NOTED "MOSTLY RESOLVED BUT STILL LOOKS PINKISH AND DID NOT RETURN TO 100%."

  Patient problems: Obstruction/Occlusion

  MAUDE report 15893972 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE SUBCUTANEOUS PLANE OF THE MENTAL CREASE WITH 0.15 CC JUVÉDERM® ULTRA PLUS XC. THE INJECTOR WENT DOWN TO THE BONE AND ASPIRATED FIRST TO CHECK FOR VASCULATURE. THE PATIENT HAD ¿INITIAL SORENESS.¿ APPROXIMATELY 24-48H LATER, THE PATIENT REPORTED ¿PAIN¿ IN THE GUMS AND GENERAL JAW AREA AND VISUALIZED ¿SMALL, PIMPLE-LIKE LESION WITH PUS COMING OUT¿ OF THE INJECTION SITE. THE PATIENT WAS TREATED WITH DOXYCYCLINE FOR 10 DAYS, ASA 325, AND A WARM COMPRESS THE NEXT DAY. THE PATIENT HAS A HISTORY OF BACK ISSUES AND HYPOTHYROIDISM, A HISTORY OR PREVIOUS JUVÉDERM® ULTRA AND JUVÉDERM® ULTRA PLUS AND TAKES SYNTHROID CONCOMITANTLY. THE EVENT IS ONGOING, BUT THE SWELLING HAS COME DOWN.

  Patient problems: Abscess

  MAUDE report 15886109 ↗
• InjurySep 8, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED ¿PATIENT IS EXPERIENCING BLANCHING ABOVE THE LIPS THAT SHOWED UP IMMEDIATELY¿ AFTER THEY WERE INJECTED IN THE LEFT VERMILLION BORDER JUVÉDERM® ULTRA PLUS XC. PATIENT WAS TREATED WITH HYLENEX THAT DAY, THE NEXT DAY AND TWO DAYS AFTERWARD. SYMPTOMS IS BETTER BUT STILL ONGOING.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 15381978 ↗
• InjuryAug 17, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED WITH 0.2ML OF JUVÉDERM® ULTRA PLUS XC IN THE NLF AND POSSIBLY EXPERIENCED VASCULAR COMPROMISE DURING INJECTION. PATIENT WAS TREATED WITH HYLENEX, VIAGRA, STEROIDS, TOPICAL NITROPASTE, ASPIRIN AND ¿HYPERBARIC O2THECA¿ SAME DAY. SYMPTOMS FULLY RESOLVED THE NEXT DAY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15241199 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED IN ORAL COMMISSURES AND MARIONETTE LINES WITH JUVÉDERM® ULTRA XC. SEVEN MONTHS LATER, PATIENT WAS INJECTED IN ORAL COMMISSURES, MARIONETTE LINES, AND PRE-JOWL WITH JUVÉDERM® ULTRA XC. THREE YEARS LATER, PATIENT WAS INJECTED IN UPPER/LOWER LIP LINES, ORAL COMMISSURES, AND MARIONETTE LINES WITH JUVÉDERM VOLLURE¿ XC. FOURTEEN MONTHS LATER, PATIENT WAS INJECTED IN ORAL COMMISSURES AND MARIONETTES LINES WITH JUVÉDERM® ULTRA XC AND IN UPPER LIP WITH JUVÉDERM VOLBELLA® XC. ONE MONTH LATER, PATIENT WAS INJECTED IN ORAL COMMISSURES AND NASOLABIAL FOLDS WITH 1ML JUVÉDERM® ULTRA PLUS XC. ONE MONTH LATER, PATIENT WAS INJECTED IN UPPER LIP WITH JUVÉDERM VOLLURE¿ XC. TWENTY MONTHS LATER, PATIENT DEVELOPED EDEMA IN MARIONETTE LINES. PATIENT WAS TREATED WITH 0.4CC HYLENEX®. SIX WEEKS LATER, PATIENT WAS TREATED WITH 0.4CC HYLENEX® IN ORAL COMMISSURES, MARIONETTES LINES, AND RIGHT NASOLABIAL FOLD. SIX WEEKS LATER, PATIENT WAS TREATED WITH 0.3CC HYLENEX® IN ORAL COMMISSURES. ONE MONTH LATER, PATIENT WAS TREATED WITH 0.3CC HYLENEX® IN ORAL COMMISSURES. ONE MONTH LATER, PATIENT WAS TREATED WITH 0.4CC HYLENEX® IN ORAL COMMISSURES AND WAS PRESCRI

  Patient problems: Nodule

  MAUDE report 15142993 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED IN THE MALAR CHEEKS AND JAWLINE WITH 1 ML OF JUVÉDERM® VOLUMA¿ XC, IN THE VERMILLION LIP AND SUPERIOR CUTANEOUS LIP WITH 1 ML OF JUVÉDERM® VOLBELLA¿ XC, AND IN THE NASOLABIAL FOLDS WITH 1 ML OF JUVÉDERM® ULTRA PLUS XC. SIX MONTHS LATER, THE PATIENT REPORTED ¿SWOLLEN, SORE, PINK NODULES¿ AT THE MALAR CHEEKS AND SUPERIOR CUTANEOUS LIP. THAT SAME DAY, THE PATIENT WAS PRESCRIBED LISINOPRIL 5 MG FOR 5 DAYS. THE PATIENT RETURNED 6 DAYS LATER WITH LITTLE IMPROVEMENT AND WAS TOLD TO CONTINUE LISINOPRIL 5 MG FOR 7 MORE DAYS. AFTER THE 7 DAYS, THE PATIENT RETURNED WITH LITTLE IMPROVEMENT AND THE LISINOPRIL WAS UPPED TO 10 MG FOR 7 DAYS, WITH A MEDROL DOSEPAK AND A ROUND OF DOXYCYCLINE ADDED. THE EVENT IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2022-00318 (ALLERGAN COMPLAINT # (B)(4)) AND MDR ID# 3005113652-2022-00319 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE THIRD SUSPECT PRODUCT, JUVÉDERM® ULTRA PLUS XC.

  Patient problems: Nodule

  MAUDE report 14650791 ↗