JUVEDERM VOLLURE XC 95661Recalls & reported problems

Summary

The FDA's MAUDE database contains 380 adverse event reports that list this exact device (DI 10888628034488), received between May 2, 2017 and Sep 17, 2026 — classified as 319 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (29 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 380 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that a patient reported that a patient was injected in the CK1, CK2, and CK 3 using JUVÉDERM® VOLUMA¿ XC and JUVÉDERM® VOLLURE¿ XC The patient developed nodules in the marionette.Additionally, the healthcare professional reported that the patient was injected with JUVÉDERM® VOLUMA¿ XC in the CK1, CK2, and CK3, and 1 mL of JUVÉDERM® VOLLURE¿ XC in the M1, M2, M3 The patient developed nodules and tenderness. The HCP treated the patient with hylenex a year ago, and the next treatment was 5 months ago. The symptoms have resolved.

  Patient problems: Nodule

  MAUDE report 50803083 ↗
• InjuryJul 28, 2026Off-Label Use

  Healthcare professional reported injecting a patient in the midface with 2 syringes of JUVÉDERM® VOLUMA¿ XC and in the lips with JUVÉDERM® VOLLURE¿ XC. Ten days later, the patient experienced ¿swelling.¿ At 3 weeks, the patient felt ¿significant lumps and bumps.¿ The patient was advised to see their primary care physician who did not find any abnormalities. The patient started antihistamines that month. Two months later, the patient was treated with 150 units of Hylenex, and the antihistamines were restarted. Ten days later, the events had improved, with the lower lip no longer bumpy, and most of the swelling in the upper lip. Event was ongoing.This file captured the JUVÉDERM® VOLLURE¿ XC.

  Patient problems: Inflammation; Subcutaneous Nodule

  MAUDE report 50063480 ↗
• 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 50060812 ↗
• 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 50060787 ↗
• InjuryApr 22, 2026Off-Label Use

  .HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH JUVÉDERM VOLUMA® XC. TEN MONTHS LATER, PATIENT WAS INJECTED WITH JUVÉDERM VOLLURE¿ XC. FOUR MONTHS LATER, PATIENT WAS INJECTED WITH JUVÉDERM VOLBELLA® XC. HCP REPORTED THE PATIENT WAS EXPERIENCING "HYPERSENSITIVITY". HCP LATER REPORTED PATIENT WAS EXPERIENCING DELAYED ONSET NODULES IN THE LIPS, NASOLABIAL FOLDS, CHEEKS, AND MARIONETTE LINES. SYMPTOMS BEGAN 6 DAYS POST A MICRO NEEDLING SESSION WITH PLATED EXOSOMES. PATIENT WAS TREATED WITH 2 DISSOLUTION TREATMENTS 12 DAYS APART. HCP LATER REPORTED PATIENT HAD "PERIORBITAL EDEMA DURING FLARE". PATIENT VISITED URGENT CARE AND HAD BLOODWORK DONE WHICH DID NOT SHOW AN INFECTION. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. A TSK 25G 1.5" CANNULA WAS USED. THIS RELATES TO JUVÉDERM VOLLURE¿ XC.

  Patient problems: Nodule

  MAUDE report 24957790 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED BEING INJECTED WITH TWO SYRINGES OF JUVÉDERM VOLLURE¿ XC IN THE JAWLINE AND CHIN AREA AND ONE SYRINGE OF JUVÉDERM VOLUMA® XC IN THE LIPS AND LEFT-SIDE OF CHEEK AREA. ONE YEAR LATER, PATIENT EXPERIENCED "BURNING, REDNESS, INFLAMMATION, REACTED IMMEDIATELY AFTER INJECTIONS". PATIENT ADDITIONALLY REPORTED THEY (NON-DEVICE RELATED) "FELT LIKE IT WAS NOT RIGHT, LIGHT SENSITIVITY, DIZZINESS, FELT WEIRD, FULLNESS, BRAIN FOG, EARS INFECTED, FACIAL PAIN" AS WELL AS "FEELING STRANGE, GRANULOMAS FORMING AT INJECTION SITES, LATE ONSET REACTION TO HA, LUMPS, BEING DIAGNOSED WITH (NON-DEVICE RELATED) PNEUMONIA, SINUSITIS AND A MAJOR ILLNESS". PATIENT RECEIVED N UNKNOWN ANTIBIOTIC AND "FLOODED LOWER FACE LUMPS WITH HYALURONIDASE WHICH BURNED AND HURT SO BAD AND DID NOTHING TO THE LUMPS". APPROXIMATELY 2 WEEKS LATER, PATIENT WAS TREATED WITH MORE HYALURONIDASE, WHICH THEY SAID MADE THEM "SO SICK FROM WHAT FELT LIKE POISON RUNNING THROUGH MY BODY". PATIENT NOTED "EVERY TIME I GET SICK OR MY IMMUNE SYSTEM IS COMPROMISED LUMPS FORM THEN GO BACK DOWN FOR A LONG TIME NOW RESULTING IN MY LEFT-CHEEK AND CHIN AREA PUFFING UP" AND THE "FILLER LUMPS IN LIPS ARE INFLAMED". PATIENT NOTED AN M

  Patient problems: Unspecified Infection

  MAUDE report 24866610 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED BEING INJECTED WITH TWO SYRINGES OF JUVÉDERM VOLLURE¿ XC IN THE JAWLINE AND CHIN AREA AND ONE SYRINGE OF JUVÉDERM VOLUMA® XC IN THE LIPS AND LEFT-SIDE OF CHEEK AREA. ONE YEAR LATER, PATIENT EXPERIENCED "BURNING, REDNESS, INFLAMMATION, REACTED IMMEDIATELY AFTER INJECTIONS". PATIENT ADDITIONALLY REPORTED THEY (NON-DEVICE RELATED) "FELT LIKE IT WAS NOT RIGHT, LIGHT SENSITIVITY, DIZZINESS, FELT WEIRD, FULLNESS, BRAIN FOG, EARS INFECTED, FACIAL PAIN" AS WELL AS "FEELING STRANGE, GRANULOMAS FORMING AT INJECTION SITES, LATE ONSET REACTION TO HA, LUMPS, BEING DIAGNOSED WITH (NON-DEVICE RELATED) PNEUMONIA, SINUSITIS AND A MAJOR ILLNESS". PATIENT RECEIVED N UNKNOWN ANTIBIOTIC AND "FLOODED LOWER FACE LUMPS WITH HYALURONIDASE WHICH BURNED AND HURT SO BAD AND DID NOTHING TO THE LUMPS". APPROXIMATELY 2 WEEKS LATER, PATIENT WAS TREATED WITH MORE HYALURONIDASE, WHICH THEY SAID MADE THEM "SO SICK FROM WHAT FELT LIKE POISON RUNNING THROUGH MY BODY". PATIENT NOTED "EVERY TIME I GET SICK OR MY IMMUNE SYSTEM IS COMPROMISED LUMPS FORM THEN GO BACK DOWN FOR A LONG TIME NOW RESULTING IN MY LEFT-CHEEK AND CHIN AREA PUFFING UP" AND THE "FILLER LUMPS IN LIPS ARE INFLAMED". PATIENT NOTED AN M

  Patient problems: Granuloma

  MAUDE report 24866602 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT INJECTED IN THE LIPS WITH 1ML OF JUVÉDERM® VOLBELLA¿ XC, IN THE SMILE LINE WITH 1ML OF JUVÉDERM®VOLLURE¿ XC AND IN THE JAWLINE, CHECKS AND PREJOWL SULCUS WITH 1ML OF JUVÉDERM® VOLUMA¿ XC PRESENT "DELAYED ONSET NODULES AFFECTING RIGHT LOWER LIP, AND BILATERAL JAWLINE". LATER HEALTHCARE PROFESSIONAL REPORTED APPROXIMATELY TWO MONTHS AFTER INJECTION PATIENT HAD A LIP TOUCH UP AND "PATIENT NOTICED SWELLING OF THE RIGHT SIDE LOWER LIP" AND SIX DAYS LATER "LEFT SIDED JAWLINE INFLAMMATION" AND THEN "SWELLING PROGRESSED TO THE RIGHT SIDE OF THE JAWLINE WITH NODULE FORMATION", HEALTHCARE PROFESSIONAL ALSO INDICATE "BILATERAL JAWLINE SWELLING WITH NODULE FORMATION AND LOWER LIP SWELLING WITH NODULE FORMATION" AND "INFLAMMATION OF LIPS AND FILLER MIGRATION". PATIENT WAS PRETREATMENT WITH TOPICAL OINTMENT NAXEXIS OINTMENT AND POSTTREATMENT WITH ICE AND FOR THE SYMPTOMS PATIENT WAS TREATMENT WITH DOXYCYCLINE 100MG TWICE A DAY FOR 14DAYS. EVENT IS ONGOING. THIS RECORD IS FOR THE PRODUCT JUVÉDERM®VOLLURE¿ XC.

  Patient problems: Nodule

  MAUDE report 24507846 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH ONE SYRINGE EACH OF JUVÉDERM VOLUMA® XC AND JUVÉDERM VOLLURE¿ XC. TWO WEEKS BEFORE, THE PATIENT WENT IN FOR CONSULT AND THEY ¿HAD A NODULE IN THEIR LIP FROM RHA PRODUCT.¿ APPROXIMATELY THREE MONTHS POST INJECTIONS, THE PATIENT WENT IN ¿WITH A FEW NODULES HOWEVER NOT EXACTLY WHERE VOLUMA OR VOLLURE WAS PLACED.¿ THE FOLLOWING MONTH THE PATIENT HAD ¿PERIODONTAL AND SINUS SURGERY.¿ THEN THE FOLLOWING MONTH, THE PATIENT WAS TREATED WITH 300U HYLENEX® AND PRESCRIBED ANTIBIOTICS AND PREDNISONE. THE DAY AFTER, THE PATIENT WAS TREATED AGAIN WITH 100U HYLENEX®TO DISSOLVE. FOUR DAYS LATER, THE HCP SAW THE PATIENT AGAIN AND THEY SUSPECTED THE PATIENT MAY HAVE AN UNDIAGNOSED AUTO-IMMUNE DISORDER. HCP SAID PATIENT LOOKS LIKE THEY HAVE BILATERAL PERIORAL CELLULITIS AND ADVISED THE PATIENT TO GO TO ER AND REQUEST IV ANTIBIOTICS. SYMPTOMS ARE ONGOING. HCP ADDITIONALLY REPORTED INJECTING THE PATIENT WITH 1ML OF JUVÉDERM VOLUMA® XC IN THE ¿JAWLINE AND CHIN SHADOWS,¿ AND WITH 1ML OF JUVÉDERM VOLLURE¿ XC IN THE NL FOLDS, LIPS AND MARIONETTE LINES (GLAZING).¿ APPROXIMATELY THREE WEEKS POST INJECTIONS, THERE WAS A ¿SMALL BLEP OF VOLLURE SUPE

  Patient problems: Abscess

  MAUDE report 24203853 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE NASOLABIAL FOLDS AND MARIONETTE LINES WITH 2 SYRINGES OF JUVÉDERM VOLLURE¿ XC. SIX MONTHS LATER, THE PATIENT WAS INJECTED IN THE NASOLABIAL FOLDS WITH 1 SYRINGE OF JUVÉDERM VOLLURE¿ XC. TWENTY-ONE MONTHS LATER, THE PATIENT EXPERIENCED ¿PAIN, SWELLING, AND NODULES¿ IN THE NASOLABIAL FOLDS AND MARIONETTE LINES. AN ULTRASOUND WAS PERFORMED BY A DERMATOLOGIST, WHERE NO CYSTS WERE FOUND. FOUR MONTHS AFTER ONSET, THE PATIENT CONTACTED THE INJECTING HEALTHCARE PROFESSIONAL AND WAS TREATED WITH HYLENEX. MORE HYLENEX WAS GIVEN 12 DAYS LATER, AGAIN 2 DAYS LATER, A WEEK LATER, FIVE DAYS LATER, AND TWO DAYS LATER. THE EVENT ACHIEVED 90% CLEARANCE. EVENT IS ONGOING. THIS FILE CAPTURED THE INITIAL INJECTION.

  Patient problems: Nodule

  MAUDE report 24047507 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE NASOLABIAL FOLDS AND MARIONETTE LINES WITH 2 SYRINGES OF JUVÉDERM VOLLURE¿ XC. SIX MONTHS LATER, THE PATIENT WAS INJECTED IN THE NASOLABIAL FOLDS WITH 1 SYRINGE OF JUVÉDERM VOLLURE¿ XC. TWENTY-ONE MONTHS LATER, THE PATIENT EXPERIENCED ¿PAIN, SWELLING, AND NODULES¿ IN THE NASOLABIAL FOLDS AND MARIONETTE LINES. AN ULTRASOUND WAS PERFORMED BY A DERMATOLOGIST, WHERE NO CYSTS WERE FOUND. FOUR MONTHS AFTER ONSET, THE PATIENT CONTACTED THE INJECTING HEALTHCARE PROFESSIONAL AND WAS TREATED WITH HYLENEX. MORE HYLENEX WAS GIVEN 12 DAYS LATER, AGAIN 2 DAYS LATER, A WEEK LATER, FIVE DAYS LATER, AND TWO DAYS LATER. THE EVENT ACHIEVED 90% CLEARANCE. EVENT IS ONGOING. THIS FILE CAPTURED THE ADDITIONAL INJECTION.

  Patient problems: Nodule

  MAUDE report 24047424 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) ADDITIONALLY REPORTED INJECTING THE PATIENT WITH 1ML OF JUVÉDERM VOLUMA® XC IN THE ¿JAWLINE AND CHIN SHADOWS,¿ AND WITH 1ML OF JUVÉDERM VOLLURE¿ XC IN THE NL FOLDS, LIPS AND MARIONETTE LINES (GLAZING).¿ APPROXIMATELY THREE WEEKS POST INJECTIONS, THERE WAS A ¿SMALL BLEP OF VOLLURE SUPERFICIAL, 18G NEEDLE PRODUCT EXPRESSED EASILY. NO PROBLEMS. HAPPY WITH RESULTS. ABOUT THREE MONTHS LATER, THE PATIENT WAS INJECTED WITH BOTOX® AND HAD LIP NODULES SMALL NOT TENDER, HCP THOUGHT TO BE FROM PRIOR RHA. THAT SAME WEEK THE PATIENT HAD 2 DENTAL IMPLANTS AND EXPERIENCED AN ABSCESS AND THE INFECTION SPREAD TO FILLER. THE PATIENT WAS TREATED WITH AMOX. TWO DAYS LATER, THE PATIENT HAD AN ULTRASOUND IN OFFICE AND THE RESULTS WERE SEVERE TISSUE SWELLING. TWO WEEKS LATER, OVER A PHONE CALL THE PATIENT ADVISED THE HCP THEY HAD AN ¿OV NODULE NEW UNDER CHIN.¿ THE PATIENT WAS TREATED WITH MEDROL DOSE PACK. THE FOLLOWING WEEK, THE PATIENT EXPERIENCED ¿SEVERE SWELLING IN THE LOWER FACE, LIPS, JAWLINE, AND UNDER RIGHT EYE. COULD NOT FEEL NODULES DUE TO SEVERE SWELLING.¿ THE PATIENT WAS TREATED WITH 300 UNITS HYLENEX®, KENALOG 40MG IM CIPRO500MG BID X 10 DAYS, AND XYZAL 5MG BID.

  Patient problems: Cellulitis; Nodule

  MAUDE report 23843427 ↗
• InjuryNov 21, 2025Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LIPS WITH JUVÉDERM VOLLURE¿ XC. ABOUT FOUR MONTHS LATER, PATIENT DEVELOPED NODULES IN THE LIPS. PATIENT WAS PRESCRIBED PEPCID AND CLARITIN DAILY AND RECEIVED A "FULL DISSOLVE" WITH HYLENEX. THE PACKAGED NEEDLE WAS USED. THIS WAS THE INITIAL USE OF THE SYRINGE.

  Patient problems: Subcutaneous Nodule

  MAUDE report 23624769 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED BEING INJECTED WITH ONE SYRINGE OF JUVÉDERM VOLLURE¿ XC IN THE MARIONETTE LINES. THE PATIENT EXPERIENCED ¿LATE ONSET NODULES WHICH ARE REALLY PRESENT AND NOTICEABLE, BUMPS, BRUISING, HARDNESS, THROBS AND SENSATIONS, ITCHY ONE SPOT, AND RIPPLES ON THE SIDE OF MOUTH." NO TREATMENT HAS BEEN PROVIDED. THE SYMPTOMS ARE ONGOING.

  Patient problems: Nodule

  MAUDE report 22338498 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE NASOLABIAL FOLDS AND ORAL COMMISSURES WITH 1.4 ML OF JUVÉDERM® VOLLURE¿ XC. TWO MONTHS LATER, THE PATIENT WAS INJECTED IN THE NASOLABIAL FOLDS, MARIONETTE LINES, AND LIPS WITH 1.1 ML OF JUVÉDERM® VOLLURE¿ XC AND IN THE VERTICAL LIP LINES WITH 0.5 ML OF SKINVIVE¿ BY JUVÉDERM®. A MONTH LATER, THE PATIENT REPORTED ¿SWELLING AND PAIN¿ AND WAS TREATED WITH HYLENEX 50 UNITS. FOUR DAYS LATER, THE PATIENT REPORTED ¿INCREASED NODULES,¿ UNILATERAL TO THE LEFT SIDE OF THE NASOLABIAL FOLDS AND TOP LIP. CMAC TREATMENT WAS INITIATED WITH PREDNISONE 60 MG X 4 DAYS TO TAPER TO 20 MG EVERY 4 DAYS UNTIL FINISHED. THREE DAYS LATER, THE PATIENT EXPERIENCED ¿BILATERAL NODULES¿ IN THE MARIONETTE LINES, NASOLABIAL FOLDS, TOP LIP AND SUPER LIP AREA THAT WAS ¿SWOLLEN AND PAINFUL.¿ THE NEXT DAY, THE PATIENT RECEIVED A SECOND HYLENEX TREATMENT WITH 300 UNITS AND CONTINUED TO TAKE PREDNISONE. A WEEK LATER, THE PATIENT WAS ADDITIONALLY TREATED WITH HYLENEX AND PREDNISONE. THE PATIENT LATER DISCLOSED THAT THEY HAD BEEN RECEIVING ALLERGY SHOTS EVERY 2 WEEKS FOR SEVERE DOG ALLERGIES AND THEIR LAST SHOT WAS 3 DAYS PRIOR TO ONSET. EVENT IS ONGOING. THIS FI

  Patient problems: Nodule

  MAUDE report 22099837 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE NASOLABIAL FOLDS AND ORAL COMMISSURES WITH 1.4 ML OF JUVÉDERM® VOLLURE¿ XC. TWO MONTHS LATER, THE PATIENT WAS INJECTED IN THE NASOLABIAL FOLDS, MARIONETTE LINES, AND LIPS WITH 1.1 ML OF JUVÉDERM® VOLLURE¿ XC AND IN THE VERTICAL LIP LINES WITH 0.5 ML OF SKINVIVE¿ BY JUVÉDERM®. A MONTH LATER, THE PATIENT REPORTED ¿SWELLING AND PAIN¿ AND WAS TREATED WITH HYLENEX 50 UNITS. FOUR DAYS LATER, THE PATIENT REPORTED ¿INCREASED NODULES,¿ UNILATERAL TO THE LEFT SIDE OF THE NASOLABIAL FOLDS AND TOP LIP. CMAC TREATMENT WAS INITIATED WITH PREDNISONE 60 MG X 4 DAYS TO TAPER TO 20 MG EVERY 4 DAYS UNTIL FINISHED. THREE DAYS LATER, THE PATIENT EXPERIENCED ¿BILATERAL NODULES¿ IN THE MARIONETTE LINES, NASOLABIAL FOLDS, TOP LIP AND SUPER LIP AREA THAT WAS ¿SWOLLEN AND PAINFUL.¿ THE NEXT DAY, THE PATIENT RECEIVED A SECOND HYLENEX TREATMENT WITH 300 UNITS AND CONTINUED TO TAKE PREDNISONE. A WEEK LATER, THE PATIENT WAS ADDITIONALLY TREATED WITH HYLENEX AND PREDNISONE. THE PATIENT LATER DISCLOSED THAT THEY HAD BEEN RECEIVING ALLERGY SHOTS EVERY 2 WEEKS FOR SEVERE DOG ALLERGIES AND THEIR LAST SHOT WAS 3 DAYS PRIOR TO ONSET. EVENT IS ONGOING. THIS FI

  Patient problems: Nodule

  MAUDE report 22099836 ↗
• InjuryMar 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED IN EACH TEMPLE WITH 1CC OF JUVÉDERM VOLUMA® XC, AND WITH JUVÉDERM VOLLURE¿ XC WITH 0.7CC IN THE RIGHT SIDE ZYGOMA AND 0.30CC IN THE LEFT SIDE. APPROXIMATELY TWO WEEKS POST INJECTIONS THE HCP SAW THE PATIENT ¿FOR A PERSISTENT 7/10 NONRADIATING PRESSURE LIKE HEADACHE, WORSE ON RIGHT SIDE AND WITH BENDING FORWARD.¿ AN ULTRASOUND WILL BE PERFORMED ¿BECAUSE THE HCP BELIEVES THERE IS A VENOUS OCCLUSION.¿ SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) (EMDR-(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLLURE¿ XC.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21668005 ↗
• InjuryOct 22, 2024Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS INJECTED IN THE LIPS WITH 0.7 ML OF JUVÉDERM® VOLLURE¿ XC. FOUR WEEKS LATER, THE PATIENT WAS INJECTED IN THE LIPS WITH 0.3 ML OF JUVÉDERM® VOLLURE¿ XC. WITHIN THE NEXT 3 MONTHS, THE PATIENT EXPERIENCED POSSIBLE GRANULOMAS (BIOPSY WAS NOT PROVIDED), ONE LARGE NODULE ON THE RIGHT LOWER LIP, ONE SMALL NODULE IN CORNER OF THE LEFT LOWER LIP, AND A SMALL NODULE ABOVE THE LEFT LOWER LIP. THE PATIENT WAS TREATED WITH HYLENEX AND AGAIN A WEEK LATER. EVENT IS ONGOING. THIS EMDR IS BEING SUBMITTED FOR 2ND INJECTION.

  Patient problems: Nodule

  MAUDE report 20510238 ↗
• InjuryOct 22, 2024Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS INJECTED IN THE LIPS WITH 0.7 ML OF JUVÉDERM® VOLLURE¿ XC. FOUR WEEKS LATER, THE PATIENT WAS INJECTED IN THE LIPS WITH 0.3 ML OF JUVÉDERM® VOLLURE¿ XC. WITHIN THE NEXT 3 MONTHS, THE PATIENT EXPERIENCED POSSIBLE GRANULOMAS (BIOPSY WAS NOT PROVIDED), ONE LARGE NODULE ON THE RIGHT LOWER LIP, ONE SMALL NODULE IN CORNER OF THE LEFT LOWER LIP, AND A SMALL NODULE ABOVE THE LEFT LOWER LIP. THE PATIENT WAS TREATED WITH HYLENEX AND AGAIN A WEEK LATER. EVENT IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) (B)(4). THIS EMDR IS BEING SUBMITTED FOR1ST INJECTION.

  Patient problems: Nodule

  MAUDE report 20510113 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED THE PATIENT WAS INJECTED IN THE NASOLABIAL FOLDS WITH 1ML OF JUVÉDERM VOLLURE¿ XC. TWO DAYS AFTER THE PATIENT EXPERIENCED ¿AN ABSCESS ON THEIR NASOLABIAL FOLD¿. THREE DAYS LATE THE PATIENT WAS TREATED WITH AMOXICILLIN AND ANOTHER THREE DAYS LATER THE HCP PERFORMED AN ¿IND CULTURE¿ AND THE RESULTS WERE NEGATIVE. ABOUT ONE WEEK LATER THE SYMPTOMS RESOLVED BUT THE EVENT LED TO PERMANENT DAMAGE. PATIENT HAS A DEEP VOLUME LOSS IN INJECTED AREA. PATIENT LEFT NASOLABIAL WERE FOLD AS WELL RIGHT. LEFT NASOLABIAL WASHED WITH ETOH, H&D, PURACYN-PLUS THEN INJECTED W/ LIDOCAINE AT ENTRY POINT AND 25G BLUNT CATHETER. NO BLEEDING , PAIN OR ANY OTHER COMPLICATIONS OCCURRED. DEVICE HAS BEEN DISCARDED. SYMPTOMS HAS BEEN RESOLVED.

  Patient problems: Abscess

  MAUDE report 18097429 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION REPORTED, PATIENT HAD GONE TO MULTIPLE EMERGENCY ROOMS/TREATING INSTITUTIONS FOR THE EVENT. AND RECEIVED UNSPECIFIED TREATMENT AT THESE. PATIENT HAD MULTIPLE CT SCANS OVER THE COURSE OF A FEW MONTHS. THE MOST RECENT CT SCAN ABOUT 4 MONTHS, AFTER EVENT ONSET WAS CLEAR NOTING, NO FILLER OR ABSCESS PRESENT. HEALTHCARE PROFESSIONAL UNSURE IF THE EVENT HAS RESOLVED.

  Patient problems: Abscess

  MAUDE report 18069404 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 0.5 ML OF JUVÉDERM VOLBELLA® XC IN THE LIPS AND 1 ML OF OF JUVÉDERM® VOLLURE¿ XC IN THE MARIONETTE LINES AND NASOLABIAL FOLDS. FOUR MONTHS LATER, PATIENT EXPERIENCED BUMP ON THE RIGHT LIP. TWO DAYS LATER, PATIENT REPORTED SWOLLEN ON LIP AND LOWER FACE. PATIENT WAS TREATED WITH MEDROL DOSE PACK. FIVE DAYS LATER, PATIENT WAS TREATED WITH 2 ML OF HYLENEX IN THE LIPS AND LOWER FACE. THE SYRINGE HAS BEEN DISCARDED. THE SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00790 (ALLERGAN COMPLAINT #PR 2854863). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 17882137 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED WITH 1 ML OF JUVÉDERM VOLLURE¿ XC IN PERIORAL LINES AND 1 ML OF JUVÉDERM VOLUMA® XC IN CHIN. PATIENT EXPERIENCED "LACERATED NODULES." HCP LATER REPORTED THAT THE PATIENT HAD AN ABSCESS ON THE RIGHT CHEEK AND SUSPECTS IT WAS DUE TO DENTAL SOURCE. THERE ARE SOME PENDING BIOPSIES AND THERE MAY BE POSSIBLY A TOOTH REMOVAL. THE SYMPTOMS HAVE NOT FULLY RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00665 (ALLERGAN COMPLAINT (B)(4). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM VOLLURE¿ XC.

  Patient problems: Abscess

  MAUDE report 17561069 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LIPS WITH 1 SYRINGE OF JUVÉDERM® VOLLURE¿ XC AND IN THE CHIN WITH 1 SYRINGE OF JUVÉDERM® VOLUMA¿ XC. THE PATIENT EXPERIENCED ¿HELICOBACTER PYLORI¿ AND THE LIPS ¿SWELLED.¿ THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS. THE LIP HAD A ¿GRANULOMA, LIKELY INFLAMMATORY, SWOLLEN, HOT AND RED, PAINFUL¿ AND THE ¿PALPABLE NODULES¿ WERE ¿FIRM.¿ BIOPSY WAS NOT PROVIDED. THE EVENT IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00600 (ABBVIE COMPLAINT #PR (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® VOLLURE¿ XC.

  Patient problems: Bacterial Infection; Nodule

  MAUDE report 17427808 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH TWO SYRINGES OF JUVÉDERM® VOLUMA¿ XC IN THE CHEEKS AND TWO SYRINGES OF JUVÉDERM® VOLLURE¿ XC AND IN THE MARIONETTE LINES AND CHIN. APPROXIMATELY 2 MONTHS LATER, THE PATIENT DEVELOPED 5-6 INFLAMMATORY NODULES AT INJECTION SITES. NODULES WERE ACCOMPANIED BY REDNESS AND SWELLING, BUT NO ITCHINESS OR PAIN. PATIENT WAS TREATED WITH MINOCYCLINE AND 20 MG PREDNISONE. SYMPTOMS SHOWED IMPROVEMENT OVER THE FIRST WEEK. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00466 (ABBVIE COMPLAINT #PR (B)(4). MDR ID# 3005113652-2023-00465 (ABBVIE COMPLAINT #PR (B)(4). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® VOLLURE¿ XC.

  Patient problems: Nodule

  MAUDE report 17172922 ↗