Skinvive 98307Recalls & reported problems

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 10840228300066), received between Oct 12, 2023 and Sep 15, 2026 — classified as 183 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (70 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Nodule

  MAUDE report 50766054 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported a patient was injected with SKINVIVE¿ by JUVÉDERM® into the right and left malar/zygomatic areas. Patient also concomitantly received nuera and back and cheek laser hair removal. The next day, patient reported presenting with left cheek erythema and good capillary refill. Swelling and mild tenderness also reported. Patient showed slight improvement of erythema each day. Patient was treating area with 2.5% hydrocortisone ointment and biopelle 40 serum multiple times a day. It was noted as of three days after onset the swelling remained and capillary refill was 1-2 seconds. The lower edge of the cheek area was a little darker in color and the redness of the upper edge had resolved by 75%. Patient was prescribed a medrol dose pack, starting with 4 a day then tapering. Patient also given Revivisomes, biopelle 40's 2.5% hydrocortisone, doxycycline 100mg. Patient also reportedly rook bacitracin ointment. Patient travelled overseas but returned two weeks later. It was noted the skin had cleared up, good capillary refill and very little erythema. There was a small amount of hyperpigmentation in the lower perinasal area remaining. Patient reportedly had pus

  Patient problems: Abscess

  MAUDE report 50762785 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Via clinical study, a healthcare professional reported injecting a patient in the midface, temples, and chin with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips and perioral with 1.15 mL of JUVÉDERM® VOLBELLA¿ XC, and in the cheek with 3 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the midface, chin, and temples with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips with 0.2 mL of JUVÉDERM® VOLBELLA¿ XC, in the jawline with 0.7 mL of JUVÉDERM® VOLUX¿ XC, in the nasolabial folds with 1 mL of JUVÉDERM® VOLLURE¿ XC, and in the cheek with 1 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the nasolabial folds with 0.6 mL of JUVÉDERM® VOLLURE¿ XC and in the jawline with 0.3 mL of JUVÉDERM® VOLUX¿ XC. Two months later, the patient experienced non-device related ¿left sided squamous cell carcinoma of the tongue .¿ Two days later, the patient experienced non-device related ¿Urinary Tract infection¿ and ¿dehydration.¿ The ¿dehydration¿ resolved that day, and the ¿Urinary Tract infection¿ resolved a week later. The ¿left sided squamous cell carcinoma of the tongue¿ was ongoing.

  Patient problems: Cancer

  MAUDE report 50060803 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Via clinical study, a healthcare professional reported injecting a patient in the midface, temples, and chin with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips and perioral with 1.15 mL of JUVÉDERM® VOLBELLA¿ XC, and in the cheek with 3 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the midface, chin, and temples with 5.1 mL of JUVÉDERM® VOLUMA¿ XC, in the lips with 0.2 mL of JUVÉDERM® VOLBELLA¿ XC, in the jawline with 0.7 mL of JUVÉDERM® VOLUX¿ XC, in the nasolabial folds with 1 mL of JUVÉDERM® VOLLURE¿ XC, and in the cheek with 1 mL of SKINVIVE¿ by JUVÉDERM®. A month later, the patient was injected in the nasolabial folds with 0.6 mL of JUVÉDERM® VOLLURE¿ XC and in the jawline with 0.3 mL of JUVÉDERM® VOLUX¿ XC. Two months later, the patient experienced non-device related ¿left sided squamous cell carcinoma of the tongue .¿ Two days later, the patient experienced non-device related ¿Urinary Tract infection¿ and ¿dehydration.¿ The ¿dehydration¿ resolved that day, and the ¿Urinary Tract infection¿ resolved a week later. The ¿left sided squamous cell carcinoma of the tongue¿ was ongoing.

  Patient problems: Cancer

  MAUDE report 50060720 ↗
• InjuryJul 9, 2026Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED VIA A COMPANY REPRESENTATIVE THAT A PATIENT WAS INJECTED 1 ML IN THE LIPS, UPPER LIP, SIDES OF CHIN WITH SKINVIVE¿ BY JUVÉDERM®, PATIENT PRESENTED "SENSITIVITY". LATER PHYSICIAN REPORTED "PATIENT EXPERIENCED REACTION 8 DAYS AFTER INJECTION, NODULE SWELLING TO RIGHT SIDE OF CHIN". MED DOSE PACK WAS GIVEN AS TREATMENT. THE EVENT IS ONGOING.

  Patient problems: Inflammation; Nodule

  MAUDE report 25774226 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH SKINVIVE¿ BY JUVÉDERM®. THE PATIENT EXPERIENCED ¿DIFFUSED SWELLING REDNESS.¿ THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND STEROIDS. EVENT STATUS WAS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 25613218 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH SKINVIVE¿ BY JUVÉDERM®. THE PATIENT EXPERIENCED ¿DIFFUSED SWELLING REDNESS.¿ THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND STEROIDS. EVENT STATUS WAS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 25613206 ↗
• InjuryJun 1, 2026Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH SKINVIVE¿ BY JUVÉDERM® IN THE LEFT MIDFACE WITH 0.7ML. IMMEDIATELY POST INJECTION, PATIENT EXPERIENCED "IRREGULAR, PATCHY BLANCHING WAS OBSERVED OVER THE LEFT MIDFACE. CAPILLARY REFILL TIME (CRT) WAS APPROXIMATELY 1 SECOND. THE PATIENT REPORTED NO PAIN, VISUAL DISTURBANCE, OR ABNORMAL SENSATION". BLANCHING RESOLVED SPONTANEOUSLY A FEW MINUTES POST-INJECTION AND EVOLVED INTO PURPLISH DISCOLORATION. INITIAL SYMPTOM MANAGEMENT INCLUDED 750 IU DOUBLE-DILUTED HYALURONIDASE. ONE HOUR POST-INJECTION, PURPLE COLOR REMAINED, AN ADDITIONAL 1200 IU DOUBLE-DILUTED HYALURONIDASE WAS ADMINISTERED. CRT <2 SECONDS. FIVE HOURS POST-INJECTION PATIENT NOTED MILD RED-PURPLE DISCOLORATION PERSISTED. SIXTEEN TO TWENTY-FOUR HOURS POST-INJECTION HCP NOTED THE DISCOLORATION PERSISTED BUT "REMAINED STABLE AND NON-PROGRESSIVE. THIRTY-SIX HOURS POST-INJECTION PATIENT WAS ASYMPTOMATIC AND FELT NORMAL. CRT <1 SECOND. PERSISTENT "ECCHYMOTIC DISCOLORATION CONSISTENT WITH BRUISING/VENOUS CONGESTION. NO BLISTERING, NECROSIS, OR NEUROLOGICAL SIGNS". PATIENT IS RECEIVING DAILY LOW-LEVEL RED LED LIGHT THERAPY. SYMPTOMS ARE ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25351629 ↗
• InjuryMay 26, 2026Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH ONE SYRINGE OF SKINVIVE¿ BY JUVÉDERM® TO THE PERIORAL AREA. PATIENT EXPERIENCED "RAISED BUMPS". PATIENT WAS TREATED WITH HYLENEX. ONE WEEK LATER, PATIENT WAS TREATED WITH A SECOND ROUND OF HYLENEX AND DEXAMETHASONE 10 MG. SYMPTOMS ARE ONGOING.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25279444 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE CHEEKS AND PREAURICULAR WITH 2.7 ML OF JUVÉDERM® VOLUMA¿ XC AND IN THE JAWLINE WITH 1 ML OF JUVÉDERM® VOLUX¿ XC. TWO AND HALF MONTHS LATER, THE PATIENT WAS INJECTED IN THE JAWLINE WITH 1 ML OF JUVÉDERM® VOLUX¿ XC AND IN THE CHEEKS WITH 2 ML OF SKINVIVE¿ BY JUVÉDERM®. FOUR MONTHS LATER, THE PATIENT EXPERIENCED ¿DELAYED ONSET NODULES¿ AT THE INJECTION SITES. FOR THE NEXT 11 MONTHS, THE PATIENT HAD MULTIPLE TREATMENTS WITH HYLENEX, PREDNISONE, AND ANTIHISTAMINES. TWO MONTHS POST-ONSET, AN AEROBIC + ANAEROBIC WOUND CULTURE WAS PERFORMED, RESULTING AS ¿NEGATIVE.¿ THE EVENT PARTIALLY RESOLVED AT THE END OF THE TREATMENT ROUND BUT RESURFACED 15 MONTHS LATER. THAT MONTH, THE PATIENT WAS TREATED WITH 4 COURSES OF ANTIBIOTICS (DOXYCYCLINE, CLARITHROMYCIN, AND AUGMENTIN), PREDNISONE TAPER, ANTIHISTAMINES, AND 5FU. EVENT WAS ONGOING. THIS FILE CAPTURED THE SKINVIVE¿ BY JUVÉDERM®.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25217494 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® AND EXPERIENCED BUMPS IN THE CHEEKS THAT HAVE REMAINED. ONE BUMP IS LARGER AND PALPABLE. ONE NODULE HAS SOME PAIN.

  Patient problems: Nodule

  MAUDE report 24875214 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH SKINVIVE¿ BY JUVÉDERM®. APPROXIMATELY SIX MONTHS POST INJECTIONS, THE PATIENT EXPERIENCED ¿SOME NODULAR LUMPINESS UNDER SKIN LATERAL TO RIGHT MARIONETTE LINE.¿ AN ULTRASOUND WAS PERFORMED AND IT SHOWED INFLAMMATORY TISSUE INSTEAD OF MASS APPEARANCE. THE HCP IS WONDERING IF IT IS AN IMMUNE RESPONSE TO SKINVIVE¿. THE ADVERSE EVENTS OCCURRED AFTER THEY RECEIVED THEIR SECOND SHINGLES SHOT. NO TREATMENT INFORMATION WAS PROVIDED. SYMPTOMS ARE ONGOING.

  Patient problems: Nodule

  MAUDE report 24874438 ↗
• InjuryApr 9, 2026Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE JOWL AREA WITH 2 SYRINGES OF SKINVIVE¿ BY JUVÉDERM® XC. THAT NIGHT, THE PATIENT EXPERIENCED AN ¿ALLERGIC REACTION INCLUDING SHORTNESS OF BREATH, THROAT CLOSING, TIGHTNESS IN CHEST, REDNESS, SWELLING AND BRUISING¿ IN THE JOWL AREA. THE NEXT DAY, THE PATIENT WAS PRESCRIBED A MEDROL DOSEPAK, AND THE PATIENT INDEPENDENTLY TOOK BENADRYL. EVENT WAS ONGOING.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24835940 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH SKINVIVE¿ BY JUVÉDERM®. PATIENT LATER "STARTED GETTING GROWTH ON THE ZYGOMA" AND "HAD MULTIPLE GRANULOMAS REMOVED". HCP NOTES THE PATIENT IS STILL "ACTIVELY FORMING THEM" [GRANULOMAS]. BIOPSY WAS NOT PROVIDED. SYMPTOMS ARE ONGOING.

  Patient problems: Granuloma

  MAUDE report 24794500 ↗
• InjuryApr 3, 2026Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 2MLS OF SKINVIVE¿ BY JUVÉDERM® INTO THE LOWER FACE AND MARIONETTE AREAS AND OTHER PRODUCTS, INCLUDING SYLFIRM, AND SEVEN MONTHS LATER EXPERIENCED A BUMP UNDER THE SKIN IN THE RIGHT LOWER MANDIBLE. HEALTHCARE PROFESSIONAL WONDERS IF IT COULD BE A POSSIBLE DELAYED ONSET NODULE. A CT SCAN WAS DONE ABOUT A MONTH AND A HALF AFTER ONSET NOTING "DERMAL THICKENING". A KENALOG INJECTION WAS PERFORMED AND EVENT HAS NOT RESOLVED.

  Patient problems: Subcutaneous Nodule

  MAUDE report 24783225 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPARATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SKINVIVE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Bacterial Infection

  MAUDE report 24747290 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPARATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SKINVIVE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Bacterial Infection

  MAUDE report 24747281 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPERATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SKINVIVE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Bacterial Infection

  MAUDE report 24747275 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPERATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SKINVIVE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Bacterial Infection

  MAUDE report 24747269 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPERATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SKINVIVE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Subcutaneous Nodule

  MAUDE report 24747004 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPARATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SKINVIVE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Subcutaneous Nodule

  MAUDE report 24746999 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPERATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SEPARATE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Subcutaneous Nodule

  MAUDE report 24746972 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH SKINVIVE¿ BY JUVÉDERM® ON TWO SEPARATE OCCASIONS WITH NO INCIDENT. PATIENT LATER HAD A THIRD SKINVIVE¿ BY JUVÉDERM® TREATMENT AND EXPERIENCED SMALL BUMPS ONE MONTH POST INJECTION. HYALURONIDASE WAS INJECTED AND THE BUMPS RESOLVED. PATIENT LATER UNDERWENT A FOURTH TREATMENT WITH SKINVIVE¿ BY JUVÉDERM® AND THEN FIVE MONTHS LATER EXPERIENCED THE SIMILAR BUMPS AGAIN WITH INTERMITTENT RESOLUTION. ABOUT TWO MONTHS AFTER THE RECURRENCE OF THE BUMPS, PATIENT DEVELOPED MIGRAINES AND A SINUS INFECTION THAT REQUIRED A VISIT TO THE ER. THE BUMPS HAVE CONTINUED TO PERSIST. PATIENT WAS PRESCRIBED PREDNISONE, DOXYCYCLINE, AND IV ANTIBIOTICS AT THE ER. EVENT ONGOING.

  Patient problems: Subcutaneous Nodule

  MAUDE report 24746936 ↗
• InjuryMar 30, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 0.3 ML OF SKINVIVE¿ BY JUVÉDERM® IN THE FOREHEAD AND BETWEEN THE BROWS. POST INJECTION THE HCP NOTICED THAT THE INJECTED AREA LOOKED RED, AND THEY SAW A LITTLE WHITE SPOT IN THE GLABELLA. THE HCP STATED THAT THE SKIN WAS BLANCHED, AND THEY THOUGHT IT WAS AN OCCLUSION. THE HCP TREATED THE PATIENT WITH A BOX OF HYLENEX AND THE PATIENT WAS INJECTED 1 MONTH LATER WITH 0.4 ML OF HYLENEX AGAIN. ABOUT 5 MONTHS AFTER ONSET PATIENT ALSO UNDWERWENT AN IPL(INTENSE PULSE LIGHT) THERAPY FOR THE REDNESS AND A VI PEEL ABOUT TWO WEEKS LATER. EVENT ONGOING.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24736652 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1CC OF JUVÉDERM® VOLUMA® XC IN THE CHEEKS, AND 2CC OF SKINVIVE¿ BY JUVÉDERM® IN THE CHEEKS. PATIENT CONCOMITANTLY RECEIVED 3 SYRINGES OF NON-ABBVIE VERSA IN THE CHIN AND CHEEKS, AS WELL AS 6U OF BOTOX IN THE CHIN. TWO YEARS LATER, PATIENT RECEIVED A SERIES OF NOUVADERM LASER TREATMENTS WITH EXOIE PLANT EXOSOMES. THE SECOND OCCURRED TWO MONTHS LATER USING THE NOUVADERM 1927 FRACTIONATED LASER TREATMENT. THE THIRD AND FINAL TREATMENT OCCURRED ABOUT TWO MONTHS LATER WHERE THE PATIENT RECEIVED A VI PURIFY WITH PRECISION PLUS AFTER THE NOUVADERM LASER. APPROXIMATELY TWO WEEKS LATER, PATIENT CONTRACTED COVID WHICH TRIGGERED SWELLING IN THE GLABELLA, UNDER EYES, AND LEFT CHIN/JAWBONE. PATIENT DID NOT ORIGINALLY BELIEVE THE SYMPTOMS WERE RELATED TO THE FILLER INJECTIONS 2 YEARS PRIOR. PATIENT HAD AN MRI PERFORMED. PATIENT NOTED A NODULE ON THE CHIN, LATER DESCRIBED BY THE HCP AS A GRANULOMA. HCP NOTED GRANULOMAS SEEM TO BE "IN [THE] GLABELLA ( [HCP] DIDN¿T PUT ANY FILLER THERE BUT DID TREAT [THE PATIENT] WITH BOTOX THERE" AS WELL AS IN THE UNDER EYE AREA, NEAR THE "MEDIAL CHEEK ALMOST IN THE TEAR TROUGH, AND ON [THE] RIGHT JAW". SYM

  Patient problems: Granuloma

  MAUDE report 24736200 ↗