JUVÉDERM VOLBELLA XC 96183Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10888628043749), received between Apr 6, 2022 and Apr 23, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE CHIN (MENTUM) WITH 1ML OF JUVÉDERM® VOLUMA® XC. FOUR MONTHS POST-INJECTION PATIENT RETURNED TO THE INJECTING CLINIC EXPERIENCING "PALPABLE NODULES IN THE MENTUM, CLINICALLY SUGGESTIVE OF PRODUCT MIGRATION". ON THE SAME DAY, PATIENT WAS TREATED WITH 1 VIAL HYLENEX, RECONSTITUTED WITH 0.2ML SODIUM BICARBONATE AND 0.2ML OF 2% LIDOCAINE. DURING THE TREATMENT APPOINTMENT PATIENT WAS ALSO INJECTED WITH 0.5ML OF JUVÉDERM® VOLBELLA® XC TO THE UPPER LIP. ONE MONTH LATER, PATIENT REPORTED "INTERMITTENT SWELLING OF THE BILATERAL JAWLINE AND CHIN SINCE TREATMENT. SWELLING IS FLUCTUATING, WITH EPISODES OF RESOLUTION AND RECURRENCE". PATIENT ALSO EXPERIENCED "EPISODIC SWELLING OF BOTH UPPER AND LOWER LIPS, DESCRIBED AS FIRM WHEN PRESENT. NO SWELLING OR FIRMNESS OBSERVED ON EXAM". HCP NOTED THEIR CLINICAL FINDS AS THE "CHIN APPEARS TIGHT, FIRM, AND SOMEWHAT RIGID IN CONTOUR", THE "RIGHT JAWLINE/JOWL DEMONSTRATES FULLNESS CONSISTENT WITH POSSIBLE PRODUCT MIGRATION", AND THE "LEFT JAWLINE/JOWL WITHOUT PALPABLE FIRMNESS OR VISIBLE SWELLING ON EXAM, THOUGH PATIENT REPORTS INTERMITTENT SYMPTOMS OF EPISODIC SWELLING AND FIRMNESS". PATIEN

  Patient problems: Inflammation

  MAUDE report 24969415 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  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. THE PACKAGED NEEDLE WAS USED. THIS RELATES TO JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 24957788 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 5 SYRINGES OF JUVÉDERM® VOLUMA¿ XC INTO THE CHEEKS AND TEMPLES. PATIENT RETURNED THE FOLLOWING DAY AND WAS INJECTED WITH BOTOX. THE HEALTHCARE PROFESSIONAL NOTICED THAT PATIENT HAD MINIMAL SWELLING TO THE FACE, BUT "ALL WITHIN PARAMETERS 24 HOURS POST FILLER INJECTION." A LITTLE OVER TWO WEEKS LATER, PATIENT RETURNED WITH NO CONCERNS AND WAS INJECTED WITH 1ML OF JUVÉDERM® VOLUMA¿ XC INTO THE CHEEKS AND 0.55MLS OF JUVÉDERM® VOLBELLA¿ XC INTO THE LIPS. ABOUT THREE WEEKS LATER, PATIENT HAD SWELLING IN THE LEFT CHEEK AND WAS ADVISED TO TAKE ZYRTEC. SWELLING RESOLVED. A WEEK LATER, PATIENT EXPERIENCED RIGHT CHEEK SWELLING AND A MEDROL DOSE PACK WAS STARTED. TWO DAYS LATER, THE SWELLING WAS BETTER BUT A "BUMP" BELOW THE LEFT EYE AND UPPER LIP WAS NOTED. SWELLING RETURNED 5 DAYS LATER AND ANOTHER MEDROL DOSE PACK WAS STARTED. THE SWELLING IMPROVED THE FOLLOWING DAY BUT THE BUMPS REMAINED PRESENT. 5 DAYS LATER, PATIENT WAS SEEN IN PRACTICE WITH NO SWELLING. MASSAGE AND DIRECT PRESSURE WERE APPLIED TO THE BUMPS AND THEY WERE MUCH IMPROVED. SWELLING RETURNED TWO DAYS LATER GENERALIZED IN THE CHEEKS. PREDNISONE 5MG WAS STARTED FOR 3

  Patient problems: Inflammation

  MAUDE report 24056424 ↗
• InjuryJul 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH JUVÉDERM® VOLBELLA® XC. PATIENT EXPERIENCED VASCULAR OCCLUSION. HCP TREATED THE PATIENT WITH "SEVERAL VIALS" OF HYLENEX TO "DISSOLVE THE PRODUCT". SYMPTOM RESOLUTION IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22654105 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS INJECTED WITH ONE SYRINGE OF JUVÉDERM VOLBELLA® XC IN THE UPPER AND LOWER LIPS. ABOUT 2 MONTHS LATER, PATIENT REPORTED LATE ONSET INFLAMMATION AND SMALL NODULES ON UPPER AND LOWER LIPS. PATIENT TOOK OTC ZYRTEC. HCP PRESCRIBED PATIENT THE PREDNISONE 50MG 1XA DAY FOR 7 DAYS AND DOXYCYCLINE 100 MG 2X¿S A DAY FOR 14 DAYS. THE SYRINGE AND HAS BEEN DISCARDED. THE SYMPTOMS ARE ONGOING.

  Patient problems: Nodule

  MAUDE report 22013231 ↗
• InjuryApr 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH .5 ML OF JUVÉDERM VOLBELLA® XC THE PATIENT HAD A VASCULAR OCCLUSION ON THE LOWER RIGHT SIDE OF THE LIP WHILE FANNING THE PRODUCT. VISIBLY THE PATIENT SAW SWELLING AND WHITE DISCOLORATION UP TO THE NOSE. THE HEALTHCARE PROFESSIONAL TREATED THE PATIENT WITH 0.6 ML OF HYLANEX AND MASSAGED AND APPLIED HEAT. THE PATIENT CAME BACK AND WAS TREATED WITH .5 ML OF HYLANEX.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21939911 ↗
• InjuryApr 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE LOWER RIGHT LIP WITH 0.15 ML OF JUVÉDERM VOLBELLA® XC. IMMEDIATELY AFTER, "THE AREA SWELLED AND DISCOLORATION APPEARED UP TO [THE PATIENTS] NOSE". HCP STATED "IT WAS A VASCULAR OCCLUSION". HCP INJECTED THE PATIENT WITH 0.6ML OF HYLENEX, MASSAGED, AND APPLIED HEAT TO THE AREA 30 MINUTES POST INJECTION. PATIENT RETURNED THE FOLLOWING DAY AND WAS INJECTED WITH ANOTHER 0.5ML OF HYLENEX. HCP LATER REPORTED THE PATIENT IS NOT IN PAIN, BUT HAS "BRUISING AND A MOTTLED APPEARANCE". HCP ALSO NOTED THERE WAS "CAP REFILL" AT THE INJECTION SITE. SYMPTOMS ARE ONGOING. THE PACKAGED NEEDLE WAS USED AND TIGHTENED BY HAND.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21927733 ↗
• InjuryFeb 20, 2025Adverse 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 2 SYRINGES OF JUVÉDERM VOLBELLA® XC. SIX MONTHS LATER, THE PATIENT EXPERIENCED ¿NODULES/GRANULOMAS¿ IN THE LIPS. THE PATIENT WAS INJECTED WITH HYALURONIDASE, BUT THE EVENT REMAINED. THE GRANULOMAS WERE LATER ¿CUT OUT.¿ EVENT STATUS IS UNKNOWN.

  Patient problems: Nodule

  MAUDE report 21426338 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE LIPS WITH A HALF A SYRINGE OF JUVÉDERM® VOLBELLA¿ XC. TWO WEEKS LATER, THE PATIENT WAS INJECTED WITH ADDITIONAL HALF SYRINGE OF JUVÉDERM® VOLBELLA¿ XC IN THE LIPS. EIGHT WEEKS LATER, THE PATIENT EXPERIENCED ¿SWELLING, TENDERNESS, AND BUMPS¿ TO LIPS WITH ¿MULTIPLE FIRM NODULES PRESENT AND MILD ERYTHEMA AND WARMTH." THE PATIENT WAS RECOMMENDED 50 MG OF BENADRYL X 2 DAYS. FIVE DAYS LATER, THE PATIENT RETURNED WITH WORSENING ¿SWELLING¿ TO TOP AND BOTTOM LIP. THE PATIENT WAS TREATED WITH 80MG OF KENALOG AND WAS PRESCRIBED A MEDROL DOSEPAK AND AUGMENTIN 500MG BID X 7 DAYS . THE NEXT DAY, THE PATIENT WAS TREATED WITH 1 VIAL OF HYLENEX. ONLY HALF THE VIAL WAS INJECTED DUE TO A LARGE AMOUNT OF ¿SWELLING" AND PATIENT DISCOMFORT. A WEEK LATER, THE SWELLING HAD IMPROVED AND MOST OF THE FILLER WAS DISSOLVED IN THE LOWER LIP, BUT SOME NODULES REMAINED IN THE UPPER LIP. THE PATIENT RECEIVED 2 VIALS OF HYLENEX, MAJORITY TO THE UPPER LIP. PATIENT RETURNED TO THE CLINIC ONE WEEK LATER AND LIPS HAD RETURNED TO PREVIOUS SIZE WITH NO ERYTHEMA, WARMTH, OR TENDERNESS. AT THIS VISIT, PATIENT REPORTED NEW ONSET "NUMBNESS" TO THE LEFT TOP LIP. HE

  Patient problems: Nodule

  MAUDE report 18366657 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE LIPS WITH A HALF A SYRINGE OF JUVÉDERM® VOLBELLA¿ XC. TWO WEEKS LATER, THE PATIENT WAS INJECTED WITH ADDITIONAL HALF SYRINGE OF JUVÉDERM® VOLBELLA¿ XC IN THE LIPS. EIGHT WEEKS LATER, THE PATIENT EXPERIENCED ¿SWELLING, TENDERNESS, AND BUMPS¿ TO LIPS WITH ¿MULTIPLE FIRM NODULES PRESENT AND MILD ERYTHEMA AND WARMTH." THE PATIENT WAS RECOMMENDED 50 MG OF BENADRYL X 2 DAYS. FIVE DAYS LATER, THE PATIENT RETURNED WITH WORSENING ¿SWELLING¿ TO TOP AND BOTTOM LIP. THE PATIENT WAS TREATED WITH 80MG OF KENALOG AND WAS PRESCRIBED A MEDROL DOSEPAK AND AUGMENTIN 500MG BID X 7 DAYS . THE NEXT DAY, THE PATIENT WAS TREATED WITH (B)(6) VIAL OF HYLENEX. ONLY HALF THE VIAL WAS INJECTED DUE TO A LARGE AMOUNT OF ¿SWELLING" AND PATIENT DISCOMFORT. A WEEK LATER, THE SWELLING HAD IMPROVED AND MOST OF THE FILLER WAS DISSOLVED IN THE LOWER LIP, BUT SOME NODULES REMAINED IN THE UPPER LIP. THE PATIENT RECEIVED (B)(6) VIALS OF HYLENEX, MAJORITY TO THE UPPER LIP. PATIENT RETURNED TO THE CLINIC ONE WEEK LATER AND LIPS HAD RETURNED TO PREVIOUS SIZE WITH NO ERYTHEMA, WARMTH, OR TENDERNESS. AT THIS VISIT, PATIENT REPORTED NEW ONSET "NUMBNESS" TO THE LEFT T

  Patient problems: Nodule

  MAUDE report 18366656 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HCP REPORTED INJECTING A PATIENT IN THE LIPS WITH ONE SYRINGE OF JUVÉDERM VOLBELLA® XC. 18 DAYS LATER, PATIENT WAS INJECTED IN THE LIPS WITH AN ADDITIONAL SYRINGE OF JUVÉDERM VOLBELLA® XC. 54 DAYS LATER, PATIENT STARTED EXPERIENCING SWELLING IN THE LIPS, BRUISING IN THE LIPS, WARM LIPS, AND BUMPS ON LIPS. THE SWELLING IN THE LIPS, THE LIPS WERE WARM, AND BUMPS WERE ALL RELATED AS THEY ARE INFLAMMATORY NODULES. EIGHT DAYS LATER, PATIENT WAS PROVIDED BENADRYL, KENALOG SHOT, AND ANTIBIOTICS AS TREATMENT. EVENT RESOLVED ABOUT A MONTH AND A HALF LATER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00931 (ABBVIE COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 18336434 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HCP REPORTED INJECTING A PATIENT IN THE LIPS WITH ONE SYRINGE OF JUVÉDERM VOLBELLA® XC. 18 DAYS LATER, PATIENT WAS INJECTED IN THE LIPS WITH AN ADDITIONAL SYRINGE OF JUVÉDERM VOLBELLA® XC. 54 DAYS LATER, PATIENT STARTED EXPERIENCING SWELLING IN THE LIPS, BRUISING IN THE LIPS, WARM LIPS, AND BUMPS ON LIPS. THE SWELLING IN THE LIPS, THE LIPS WERE WARM, AND BUMPS WERE ALL RELATED AS THEY ARE INFLAMMATORY NODULES. EIGHT DAYS LATER, PATIENT WAS PROVIDED BENADRYL, KENALOG SHOT, AND ANTIBIOTICS AS TREATMENT. EVENT RESOLVED ABOUT A MONTH AND A HALF LATER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00932 (ABBVIE COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 18336432 ↗
• 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# 3005113652-2023-00791 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 17882130 ↗
• InjurySep 14, 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 HALF A SYRINGE OF JUVÉDERM VOLBELLA® XC. FOUR MONTHS LATER, THE PATIENT WAS INJECTED IN THE LIPS WITH ANOTHER HALF OF A SYRINGE OF JUVÉDERM VOLBELLA® XC. A MONTH LATER, THE PATIENT REPORTED ¿TENDER AND PAINFUL NODULES¿ ON THE LIPS. THE PATIENT WAS PRESCRIBED A MEDROL DOSEPAK, WHICH WORKED BUT ONCE IT CEASED, THE EVENT RETURNED. ELEVEN DAYS LATER, THE PATIENT WAS PRESCRIBED ANOTHER MEDROL DOSEPAK AND DOXYCYCLINE. AFTER 2 WEEK, THE PATIENT¿S LIPS WERE ¿LESS INFLAMED,¿ BUT THE EVENT WOULD RETURN AFTER CEASING MEDICATION. THE PATIENT WAS TREATED THAT DAY WITH 2 VIALS OF HYLENEX AND PRESCRIBED MORE DOXYCYCLINE. THREE WEEKS LATER, IT WAS NOTED THAT THE PATIENT HAD NO REDNESS AND LESS INFLAMED LIPS, BUT THE NODULES REMAINED. THE PATIENT REPORTED ¿SWELLING¿ THE NEXT DAY. AFTER 7 WEEKS, THE NODULES WERE NO LONGER VISIBLE, BUT THE PATIENT REPORTED THAT A DIFFERENT AREA OF THEIR LIPS WOULD ¿SWELL¿ EVERY COUPLE OF DAYS AND ¿LASTING A COUPLE OF HOURS." THE PATIENT WAS TREATED THAT DAY WITH 2 VIALS OF HYLENEX. AFTER 2 WEEKS, THE PATIENT REPORTED THAT ¿RANDOM SWELLING¿ IN THE LIPS REMAINED. THE EVENT IS ONGOING. THIS IS THE SAM

  Patient problems: Nodule

  MAUDE report 17747211 ↗
• InjurySep 14, 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 HALF A SYRINGE OF JUVÉDERM VOLBELLA® XC. FOUR MONTHS LATER, THE PATIENT WAS INJECTED IN THE LIPS WITH ANOTHER HALF OF A SYRINGE OF JUVÉDERM VOLBELLA® XC. A MONTH LATER, THE PATIENT REPORTED ¿TENDER AND PAINFUL NODULES¿ ON THE LIPS. THE PATIENT WAS PRESCRIBED A MEDROL DOSEPAK, WHICH WORKED BUT ONCE IT CEASED, THE EVENT RETURNED. ELEVEN DAYS LATER, THE PATIENT WAS PRESCRIBED ANOTHER MEDROL DOSEPAK AND DOXYCYCLINE. AFTER 2 WEEK, THE PATIENT¿S LIPS WERE ¿LESS INFLAMED,¿ BUT THE EVENT WOULD RETURN AFTER CEASING MEDICATION. THE PATIENT WAS TREATED THAT DAY WITH 2 VIALS OF HYLENEX AND PRESCRIBED MORE DOXYCYCLINE. THREE WEEKS LATER, IT WAS NOTED THAT THE PATIENT HAD NO REDNESS AND LESS INFLAMED LIPS, BUT THE NODULES REMAINED. THE PATIENT REPORTED ¿SWELLING¿ THE NEXT DAY. AFTER 7 WEEKS, THE NODULES WERE NO LONGER VISIBLE, BUT THE PATIENT REPORTED THAT A DIFFERENT AREA OF THEIR LIPS WOULD ¿SWELL¿ EVERY COUPLE OF DAYS AND ¿LAS A COUPLE OF HOURS." THE PATIENT WAS TREATED THAT DAY WITH 2 VIALS OF HYLENEX. AFTER 2 WEEKS, THE PATIENT REPORTED THAT ¿RANDOM SWELLING¿ IN THE LIPS REMAINED. THE EVENT IS ONGOING. THIS IS THE SAME EV

  Patient problems: Nodule

  MAUDE report 17747161 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS INJECTED IN THE LIP/PERIORAL WITH 0.55CC JUVÉDERM VOLBELLA® XC. FOUR MONTHS LATER, THE PATIENT WAS PRESENTED WITH LATE ONSET NODULES. THE PATIENT WAS PRESCRIBED A ROUND OF STEROIDS, ANTIBIOTICS AND HYLENEX. AFTER THE STEROIDS STOPPED THE PATIENT DEVELOPED SWELLING. HCP LATER REPORTED PATIENT WENT TO URGENT CARE AND OVER THE COURSE OF A FEW WEEKS RECEIVED PREDNISONE, 24 UNITS OF HYLENEX IN NODULES VIA SUBDERMAL, AND STERAPRED DOSE PACK, AND CINTHROMYEN 500 BID FOR 2 WEEKS. PATIENT WENT TO ER AND TOOK PREDNISONE, CONTINUED STEROIDS LOW DOSE, AND DOXY SINCE THE NODULES BECAME INFLAMED. APPROXIMATELY 5 MONTHS POST INITIAL INJECTION, HCP GAVE 60 UNITS OF HYLENEX INTRADERMAL IN THE LIPS. THE PATIENT IS CONTINUING TO TAKE STEROIDS. STATUS IS ONGOING.

  Patient problems: Nodule

  MAUDE report 17725923 ↗
• InjuryJul 27, 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 1 SYRINGE OF JUVÉDERM VOLBELLA® XC AND IN THE CHEEKS WITH 2 SYRINGES OF JUVÉDERM VOLUMA® XC. APPROXIMATELY SIX MONTHS POST INJECTIONS THE PATIENT EXPERIENCED, GRANULOMAS. THE HCP ASSESSED THE PATIENT THREE WEEKS LATER THEIR DIAGNOSIS WAS THE FOLLOWING, ¿LITTLE BUMPS IN LIPS AND SWELLING SOME LUMPS IN L CHEEK WITH SWELLING AND GRANULOMAS¿. THE NEXT DAY AFTER THE ASSESSMENT THE PATIENT WAS TREATED WITH ORAL PREDNISONE/ DOXYCYCLINE. SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID#3005113652-2023-00575 (ABBVIE COMPLAINT (B)(4) ). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 17406123 ↗
• InjuryJul 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 1 SYRINGE OF .55 CC JUVÉDERM® VOLBELLA¿ XC IN THE GLABELLA. THE PATIENT REPORTED ALWAYS HAVING A "SMALL KNOT" AT THE INJECTION SITE THAT COULD FEEL. SIXTEEN MONTHS LATER, PATIENT NOTED "SWOLLEN, RED, PRURITIC" AND "VISIBLE", SWELLING AND ITCHING IN THE AREA OF THE INJECTIONS, NODULES WERE VISIBLE IN THE AREA OF INJECTIONS.TWO MONTHS LATER, THE PATIENT WAS TREATED WITH ANTIBIOTICS BY THE PRIMARY CARE PHYSICIAN. THE INJECTING PHYSICIAN TREATED THE PATIENT THAT SAME MONTH WITH STEROIDS AND WITH A MEDROL DOSEPAK AND 150 UNITS/1CC OF HYALURONIDASE A WEEK LATER. A SJOGREN¿S TEST WAS PERFORMED WHICH WAS IN NORMAL RANGE. THE SYRINGE WAS DISCARDED. THE SYMPTOMS ARE ONGOING.

  Patient problems: Nodule

  MAUDE report 17371727 ↗
• InjuryJul 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED IN THE UPPER LIP WITH A SYRINGE OF JUVÉDERM VOLBELLA® XC. ON THAT SAME DAY, AN OCCLUSION OF THE UPPER LEFT LIP OCCURRED ALONG WITH BLEEDING AND BRUISING OF THE LIP. 2100 UNITES OF HYLENEX WERE INJECTED AND A WARM COMPRESS, MASSAGE, ASPIRIN, AND NITRO PASTE ALSO PROVIDED. THE SYMPTOMS REPORTEDLY RESOLVED ON THAT SAME DATE, PATIENT WOULD HOWEVER RETURN NEXT DAY FOR ANOTHER 300 UNITS OF HYLENEX.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17326783 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT EXPERIENCED A "REALLY BAD REACTION" CLARIFIED AS "GRANULATION TISSUE FORMATION IN THE LIPS AS WELL AS A SPOT BY NOSE AND CHIN 1 CM ROUND" AFTER THEY WERE INJECTED WITH ONE SYRINGE OF JUVÉDERM® VOLBELLA¿ XC. TREATMENT IS NOTED AS 1ML OF HYALURONIDASE. BIOPSY WAS NOT PROVIDED. EVENT IS ONGOING AT THIS TIME.

  Patient problems: Nodule

  MAUDE report 16618896 ↗
• InjuryDec 22, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  VIA REGULATORY AGENCY, PATIENT REPORTED "THE NURSE THAT INJECTED THE FILLER ALL HIT THE INFRAORBITAL NERVE WHICH CAUSED SEVERE PAIN. MY FACE IS STILL NUMB AND BURNING AFTER POST 1.5 YEARS. I AM TOLD THE NERVE IS PERMANENTLY DAMAGED." THE INJECTION SITE WAS REPORTED AS "PUFFY, WITH PEA-SIZED AREAS" AND "LUMPY." THE PATIENT HAD 5-6 SESSIONS TO DISSOLVE THE FILLER, BUT REPORTS THAT THEIR FACE IS STILL "NUMB AND BURNING" 1.5 YEARS POST-INJECTION AND THE NERVE IS "PERMANENTLY DAMAGED." ADDITIONALLY, THE HEALTHCARE PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE TEAR TROUGHS WITH 0.55 ML OF JUVÉDERM® VOLBELLA¿ XC AND WITH 1 ML OF JUVÉDERM® VOLLURE¿ XC. THE EVENTS OCCURRED AT THE INJECTION SITE. THE PATIENT WAS TREATED WITH HYLENEX 3 MONTHS LATER, AGAIN 16 DAYS, AGAIN 8 DAYS LATER, AGAIN 1.5 WEEKS LATER, AND AGAIN 2 MONTHS LATER, TOTALING 10 ML. FIVE MONTHS LATER, A SOFT TISSUE ULTRASOUND WAS PERFORMED THAT RESULTED IN ¿NO EVIDENCE OF RESIDUAL FILLER, NO EVIDENCE OF SOFT TISSUE GRANULOMA, NO VISIBLE INFRAORBITAL NEURAL SWELLING, NO PERINEURAL SOFT TISSUE ABNORMALITY, UNREMARKABLE ULTRASOUND APPEARANCE OF RIGHT INFRAORBITAL NERVE AND ARTERY.¿ THE PATIENT HAD RADIOFREQUENCY MICRONEEDLING

  Patient problems: Numbness

  MAUDE report 16039687 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN EACH CHEEK WITH 0.5 JUVÉDERM VOLUMA® XC, IN THEIR UPPER LIP WITH 1 SYRINGE OF JUVÉDERM VOLBELLA® XC AND ON THEIR CROWS FEET AND BUNNY LINES WITH BOTOX . THE SAME DAY WHEN THE PATIENT OPENED THEIR EYES, THEY STATED THEY SAW A PURPLE JAGGED LINE UNDER EACH EYE. THE PATIENT WAS TREATED WITH HYALURONIDASE AND NITRO PASTE. HCP STATED "IF YOU LOOK AT THE PATIENT THERE ARE NO SIGNS OF ADVERSE EVENTS OTHER THAN THE COLOR, THEY ARE SEEING BUT WHEN WE TOOK THE PATIENT TO A DIFFERENT ROOM THE COLOR, THEY SAW CHANGED TO THE COLOR OF THE ROOM THEY WERE IN.¿ THE PATIENT WAS SENT TO A RETINA SPECIALIST BUT HAVE NOT BEEN CONTACTED WITH EXAMINATION RESULTS. EVENT STATUS IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2022-00849 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Visual Disturbances

  MAUDE report 16014819 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED IN THE LIPS WITH ONE SYRINGE OF JUVÉDERM VOLBELLA® XC. APPROXIMATELY ONE MONTH LATER, PATIENT WAS ALSO INJECTED WITH ¿RESTYLANE KYSSE UP.¿ A MONTH LATER, PATIENT EXPERIENCED SWELLING, PAIN, PUSTULES IN THE LIPS AND WHEN TOUCHED WOULD ERUPT. PATIENT ALSO DEVELOPED A RASH ON THE BELLY, DEEMED NOT DEVICE RELATED. THE PATIENT WAS TREATED WITH 4ML OF HYLENEX® AND BACTRIM. THE PATIENT EXPERIENCED A "REACTION" TO BACTRIM AFTER SIX DAYS AND WAS SWITCHED TO CLINDAMYCIN. SYMPTOMS ARE IMPROVING AND "LITTLE SKIN SLOUGHING BUT ALMOST BACK TO NORMAL."

  Patient problems: Abscess

  MAUDE report 15712803 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIA REGULATORY AGENCY (MW5111796), HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE UPPER LIP WITH 0.55 ML OF JUVÉDERM® VOLBELLA¿ XC IN THE NASOLABIAL FOLDS WITH 1 ML OF JUVÉDERM® VOLLURE¿ XC. FIVE MONTHS LATER, PATIENT EXPERIENCED SEVERE SWELLING OF THE INJECTION SITES THAT WAS MINIMALLY TENDER AND TWO VISIBLE ERYTHEMATOUS NODULES ON THE UPPER CUTANEOUS LIP. THE EVENT WAS DESCRIBED AS "LINEAR INDURATION ERYTHEMATOUS." THE PATIENT WAS TREATED WITH DOXYCYCLINE AND MEDROL DOSEPAK 4 DAYS LATER. TWELVE DAYS LATER, THE PATIENT WAS TREATED WITH PREDNISONE ¿IN A TAPERING FASHION¿ AND CLARITHROMYCIN BID X 10 DAYS. THE PATIENT HAD THE COVID-19 VACCINE 4 WEEKS PRE-ONSET. SYMPTOMS ARE RELAPSING WHEN STEROID DOSAGE IS DECREASED. PATIENT IS STILL ON STEROIDS ORALLY TO CONTROL THE INFLAMMATION. INFLAMMATION DOES NOT SEEM TO BE INFECTIOUS. ANTIBODIES HAVE NOT BEEN HELPFUL AS SYMPTOMS RELAPSE WHEN THE PREDNISONE DOSAGE DECREASED BELOW 40 MG/DAY, DESPITE 20 DAYS OF ANTIBIOTIC USE. SYMPTOM ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2022-00637 (ALLERGAN COMPLAINT (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® VOLBELLA¿ XC

  Patient problems: Nodule

  MAUDE report 15567402 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 0.55MLS OF JUVÉDERM® VOLBELLA¿ XC IN THE LIPS AND EXPERIENCED AN INFLAMMATORY RESPONSE WITH NODULES FOUR DAYS LATER IN THE "LIPS, TOP RIGHT, LOWER LEFT". PATIENT WAS PRESCRIBED 800MG OF IBUPROFEN TWICE DAILY. ABOUT TWO AND A HALF WEEKS AFTER ONSET, PATIENT WAS SEEN AND A BASELINE BLOOD PRESSURE READING TAKEN. THIS BASELINE BLOOD PRESSURE READING LEAD TO THE HEALTHCARE PROFESSIONAL PRESCRIBING PATIENT WITH 5MG OF LISINOPRIL FOR 6 DAYS. EVENTS ARE CURRENTLY ONGOING, BUT IT WAS NOTED THERE WAS A REDUCTION IN THE NODULES.

  Patient problems: Nodule

  MAUDE report 15225004 ↗