JUVÉDERM VOLBELLA XC 96181Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10888628043558), received between Feb 28, 2022 and Sep 28, 2026 — classified as 59 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (8 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 60 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Subcutaneous Nodule

  MAUDE report 50924567 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported a patient was injected with 1ml of JUVÉDERM VOLUMA® XC into the cheek and 1ml of JUVÉDERM VOLBELLA® XC. Botox was also injected. Patient later experienced an allergic reaction that made them itchy all over their body. Patient called an ambulance two days after injection. Patient also went to see their primary care physician two days later and was prescribed antibiotics and steroids. Event ongoing.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50264947 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported injecting a patient in the lips, oral commissures, perioral, and rhytids with 1 syringe syringes of JUVÉDERM® VOLBELLA¿ XC. Two months later, the patient had a dental cleaning and experienced ¿3 non-inflammatory nodules/bumps¿ later that month in the upper lip that were found via an early manual palpation. The same day as the palpation exam, the patient was on Zyrtec and had Pepcid added. Two and a half weeks later, the patient was treated with Ibuprofen 400 mg TID PO and Hyaluronidase with additional Hyaluronidase given 3 days later. Two weeks later, the patient the patient was examined again, where the number of nodules was found to have increased (7 in the upper lip and 6 in the lower lip), and the patient was treated with Doxycycline and a Medrol Dosepak that were started 3 days later. Event was ongoing.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50194629 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient was injected 2 ml with JUVÉDERM® VOLBELLA¿ XC, "Account needs to report an adverse event". Later physician reported "Hard nodule and erythema". Treated with Doxycycline 100 mg BID for 14 days, Clarithromycin 500mg BID for 28 days, Prednisone 40mg for 15 days. The event is ongoing.

  Patient problems: Nodule

  MAUDE report 50181121 ↗
• 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 50060755 ↗
• 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 50060705 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported being injected with an unspecified JUVÉDERM®. The next year, the patient experienced ¿bumps¿ all over the face, under the lips, and sides of the cheeks¿ that were described as ¿pretty thick¿ on the upper lip, some on the jawline, and on the cheekbone, the size of ¿maybe a dime or nickel.¿ A CT scan confirmed the nodules. The patient as treated with Amoxicillin that they had just completed, and steroids were considered next. The filler looked like it was ¿protruding out the sides of the face.¿ Event was ongoing.Additionally, the healthcare professional reported that the patient was injected in the cheek, lips, and jawline with 1 cc of JUVÉDERM® VOLUMA¿ XC, 1 cc of JUVÉDERM® VOLBELLA¿ XC, and 1 cc of JUVÉDERM® VOLUX¿ XC. The event occurred at the injection sites. The Amoxicillin treatment was not given by the injector, and no specifics could be given for it. Two months post-onset, the patient was treated with Keflex 500 mg PO BID. Two weeks later, the patient was treated with a Medrol Dosepak to be taken as directed and Hylenex.This file captured the JUVÉDERM® VOLBELLA¿ XC.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50009089 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  HCP REPORTED THE PATIENT RECEIVED HALF A SYRINGE OF JUVÉDERM® VOLBELLA® XC SIX MONTHS PRIOR WITH NO ADVERSE EVENT.

  Patient problems: Nodule

  MAUDE report 24593091 ↗
• InjuryMar 10, 2026Migration

  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 A MONTH AFTER INJECTION PATIENT HAD A LIP TOUCH UP WITH 1 ML OF JUVÉDERM® VOLBELLA¿ XC AND APPROXIMATELY THREE MOUNTS AFTER ORIGINAL INJECTION "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". LATER HEALTHCARE PROFESSIONAL REPORTED THAT FILLER MIGRATION WAS JUST IN LIPS. 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. PATIENT REPORT SIGNIFICANT REDUCTION IN NODULES. EVEN

  Patient problems: Nodule

  MAUDE report 24562241 ↗
• InjuryMar 4, 2026Migration

  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® VOLBELLA¿ XC.

  Patient problems: Nodule

  MAUDE report 24513776 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1ML OF JUVÉDERM® VOLBELLA® XC IN THE LIPS. PATIENT EXPERIENCED SWELLING AND LATE ONSET NODULE 6 MONTHS POST-INJECTION IN THE UPPER AND LOWER LIPS. PATIENT VISITED URGENT CARE WHERE THEY RECEIVED AN EKG AND BLOOD WORK WITH NEGATIVE TEST RESULTS. PATIENT RECEIVED PREDNISONE AT URGENT CARE. PATIENT WAS TREATED WITH 0.3CC OF HYALURONIDASE. SYMPTOMS RESOLVED AN UNKNOWN AMOUNT OF TIME AFTER INJECTION.

  Patient problems: Nodule

  MAUDE report 24248441 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS INJECTED WITH 0.5 ML OF JUVÉDERM® VOLBELLA¿ XC IN THE VERMILION LIPS. TWO MONTHS LATER, PATIENT WAS INJECTED WITH 0.3 ML OF JUVÉDERM® VOLBELLA¿ XC IN THE LIPS. TWO MONTHS LATER, PATIENT WAS INJECTED WITH 1 ML OF JUVÉDERM® VOLUMA¿ XC IN THE CHEEKS. TWO WEEKS LATER, PATIENT DEVELOPED 3 LUMPS INSIDE BOTTOM LIP AND 1 TOP RIGHT UPPER LIP AT CUPID'S BOW WITH BURNING SENSATION AND SWELLINGS. PATIENT FELT RUN DOWN WITHOUT FEVER. THE PATIENT WAS TREATED WITH STEROIDS AND VALTREX. TWO MONTHS LATER, PATIENT WAS TREATED WITH 3 ROUNDS PO STEROIDS, VALTREX, ANTIHISTAMINE, 0.2 ML OF HYLENEX, AND R/U LISINOPRIL REACTION AS CULPRIT OF ORAL SWELLING. SYMPTOMS RESOLVED APPROXIMATELY 3 MONTHS AFTER ONSET. THIS RECORD IS FOR THE 1ST INJECTION OF JUVÉDERM® VOLBELLA¿ XC.

  Patient problems: Nodule

  MAUDE report 23733377 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE CHEEK/MIDFACE, ORAL COMMISSURES, AND NASOLABIAL FOLDS WITH 1 ML OF JUVÉDERM VOLUMA® XC AND 0.6 ML OF JUVÉDERM VOLBELLA® XC. THE PATIENT NOTICED A ¿PIMPLE¿ IN EACH ORAL COMMISSURE OF THE MOUTH THAT HAD ¿OFF-WHITE COLORED DRAINAGE.¿ TWO MONTHS LATER, THE PATIENT WAS INJECTED WITH BOTOX® AND COMPLAINED OF ¿TWO SMALL BUMPS (ABOUT 2MM DIAMETER BILATERALLY IN THE ORAL COMMISSURES, CHEEKS, AND NASOLABIAL FOLDS. THE PATIENT WAS TREATED THAT DAY WITH 3 U OF HYLENEX. A WEEKS LATER, THE PATIENT THAT THEIR FACE LOOKED ¿WEIRD AND DROOPY. TWENTY-TWO DAYS LATER, THE PATIENT EXPERIENCED ¿SWELLING AND NODULES¿ IN THE CHEEKS AND MARIONETTE LINES AROUND THE MOUTH. THE HEALTHCARE PROFESSIONAL NOTED THAT THE PATIENT ¿LOST A SIGNIFICANT AMOUNT OF WEIGHT,¿ AND WHEN ASKED, THE PATIENT REPORTED ACTIVELY LOSING WEIGHT FOR 7 MONTHS BUT DID REPORT ¿STOMACH PAIN, COLD SWEATS, WEIGHT LOSS, DAILY FEVER AND RESTING HR HIGH¿ THE MONTH AFTER INJECTION. THE PATIENT ALSO REPORTED HAVING NON-DEVICE RELATED ¿SHINGLES¿ FIVE MONTHS LATER. TWO DAYS AFTER CHECK-UP, THE PATIENT WAS TREATED WITH A MEDROL DOSEPAK FOR 6 DAYS. SIX DAYS LATER, THE PATIENT WAS ALSO GIVEN

  Patient problems: Nodule; Skin Inflammation/ Irritation

  MAUDE report 23649210 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 3 SYRINGES OF JUVÉDERM® VOLUMA¿ XC INTO THE MIDFACE AND 1 SYRINGE OF JUVÉDERM® VOLBELLA¿ XC INTO THE LIPS AND CHIN SHADOWS. ABOUT 2 AND A HALF MONTHS LATER, THE PATIENT STARTED EXPERIENCING SWELLING IN THE CHIN THAT MOVED TO THE ENTIRE FACE INCLUDING THE LIPS AND CHEEKS. TWO DAYS AFTER SYMPTOM ONSET PATIENT WAS TREATED WITH A MEDROL PACK FOR 6 DAYS. AFTER COMPLETION OF THIS COURSE, PATIENT WAS STARTED ON ANOTHER MEDROL PACK AND THE FOLLOWING DAY INJECTED WITH 300 COSENTYX. PATIENT RECEIVED ANOTHER 300 COSENTYX INJECTION A WEEK LATER AND THE NEXT DAY WAS GIVEN PREDNISONE 40MG FOR 4 DAYS AND PREDNISONE 20MG FOR 4 DAYS. EVENTS ARE ONGOING. HEALTHCARE PROFESSIONAL SPECULATES THE PATIENT MAY HAVE AN UNDERLYING AUTOIMMINE CONDITION THAT HAS NOT BEEN DIAGNOSED. AUTOIMMINE CONDITION IS CONSIDERED NOT DEVICE RELATED.

  Patient problems: Autoimmune Disorder

  MAUDE report 23549741 ↗
• InjuryNov 12, 2025Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 3 SYRINGES OF JUVÉDERM® VOLUMA¿ XC INTO THE MIDFACE AND 1 SYRINGE OF JUVÉDERM® VOLBELLA¿ XC INTO THE LIPS AND CHIN SHADOWS. ABOUT 2 AND A HALF MONTHS LATER, THE PATIENT STARTED EXPERIENCING SWELLING IN THE CHIN THAT MOVED TO THE ENTIRE FACE INCLUDING THE LIPS AND CHEEKS. TWO DAYS AFTER SYMPTOM ONSET PATIENT WAS TREATED WITH A MEDROL PACK FOR 6 DAYS. AFTER COMPLETION OF THIS COURSE, PATIENT WAS STARTED ON ANOTHER MEDROL PACK AND THE FOLLOWING DAY INJECTED WITH 300 COSENTYX. PATIENT RECEIVED ANOTHER 300 COSENTYX INJECTION A WEEK LATER AND THE NEXT DAY WAS GIVEN PREDNISONE 40MG FOR 4 DAYS AND PREDNISONE 20MG FOR 4 DAYS. EVENTS ARE ONGOING. HEALTHCARE PROFESSIONAL SPECULATES THE PATIENT MAY HAVE AN UNDERLYING AUTOIMMINE CONDITION THAT HAS NOT BEEN DIAGNOSED. AUTOIMMINE CONDITION IS CONSIDERED NOT DEVICE RELATED.

  Patient problems: Inflammation

  MAUDE report 23538488 ↗
• InjurySep 5, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH ONE SYRINGE OF JUVÉDERM VOLBELLA® XC IN THE LIPS. PATIENT EXPERIENCED "BRUISING OF THE UPPER LIP" THE FOLLOWING DAY. PATIENT WAS TREATED WITH 4 VIALS OF HYLENEX, BABY ASPIRIN, VIAGRA, AND VALTREX THE NEXT DAY. HCP LATER REPORTED PATIENT BEGAN TO EXPERIENCE SWELLING AND "DUSK SKIN" 2 DAYS LATER. HCP NOTED THEY THINK THE PATIENT IS EXPERIENCING A VASCULAR OCCLUSION. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. THE PACKAGED NEEDLE WAS USED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22984765 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH TWO SYRINGES OF JUVÉDERM VOLBELLA® XC IN THE TEAR TROUGH AND MIDFACE. APPROXIMATELY 11 MONTHS POST INJECTIONS, THE PATIENT STARTED EXPERIENCING ¿IRRITATION.¿ FOUR MONTHS POST SYMPTOM ONSET, THE PATIENT SAW THEIR INJECTOR FOR THE IRRITATION. THE FOLLOWING MONTH THE PATIENT WAS SEEN AGAIN ¿FOR ONGOING IRRITATION AND SWELLING.¿ THE PATIENT WAS TREATED WITH MEDROL PACK. THREE DAYS LATER, THE PATIENT VISITED ANOTHER HCP (DERMATOLOGIST) FOR SWELLING WITH NO DIAGNOSIS. SIX DAYS LATER, THE PATIENT SAW THE SAME HCP (DERMATOLOGIST) FOR SWELLING AGAIN AND TREATED THE PATIENT WITH A STRONGER DOSE OF PREDNISONE. ABOUT TWO AND A HALF MONTHS LATER, THE HCP ORDERED A FACIAL X-RAY AND TWO DAYS LATER, THE HCP RECOMMENDED AN ¿MRI OCULAR OR ENT¿, THAT SAME DAY THE PATIENT HAD A FULL BLOOD PANEL INCLUDING AUTOIMMUNE. THE FOLLOWING DAY THE HCP SUGGESTED SEEING AN OCULAR SURGEON IMMEDIATELY. THE NEXT DAY, AN MRI WITH CONTRAST WAS PERFORMED WHICH ¿STATED IT MIGHT BE INFECTIOUS OR NEOPLASTIC. FOUR DAYS LATER, THE PATIENT SAW AN OCULOPLASTIC AND ORBITAL SURGEON WHO STATED THAT IT COULD BE THE FILLER. THE FOLLOWING DAY THE PATIENT SAW A PLASTIC SURGEO

  Patient problems: Inflammation

  MAUDE report 22889124 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE LIPS WITH 1 SYRINGE OF JUVÉDERM VOLBELLA® XC AND 1ML OF SKINVIVE¿ BY JUVÉDERM® IN THE PERIORBITAL AREA. ABOUT 3 MONTHS POST INJECTION, THE PATIENT BEGAN TO EXPERIENCE "HARD LUMPS, NODULES, SWELLING, AND LOOKED ASYMMETRIC" POST INJECTION. HCP PRESCRIBED PREDNISONE ON THE SAME DAY AS SYMPTOM ONSET. FOUR DAYS LATER, HCP INJECTED THE PATIENT WITH HYLENEX, THE PATIENT CONTINUED THE PREDNISONE AS WELL. TWO WEEKS LATER, THE PATIENT COMPLETED THE PREDNISONE TREATMENT BUT WAS STILL EXPERIENCING HARD NODULES IN THE LIP AND PERIORBITAL AREAS. SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Nodule

  MAUDE report 22680107 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH ONE SYRINGE OF JUVÉDERM VOLBELLA® XC IN THE LIPS (1 ML ACTUALLY INJECTED), AND JUVÉDERM VOLUMA® XC IN THE CHEEKS (1 ML ACTUALLY INJECTED). PATIENT EXPERIENCED "DELAYED ONSET INFLAMMATORY NODULES, LUMPINESS, REDNESS, AND SWELLING" IN THE LIPS. TREATMENT WAS PROVIDED AS AUGMENTIN, DOXYCYCLINE AND HYLENEX. SYMPTOMS ARE ONGOING.

  Patient problems: Nodule

  MAUDE report 22496520 ↗
• InjuryJul 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS INJECTED IN THE TEAR TROUGHS, INFRAORBITAL HOLLOWS OF WERE MADE WHILE MOVING FROM THE MIDLINE MORE MEDIALLY, STILL FAR FROM THE NOSE WITH 0.3ML JUVÉDERM VOLBELLA XC AND HAD A "VASCULAR OCCLUSION". HCP DID ALL PROPER STEPS ASPIRIN, FLUSHED AREA AND OBSERVED HER FOR AN HOUR. ADDITIONAL INFO PROVIDED, THE NEEDLE WAS ON THE BONE, BUT IT SLIPPED SLIGHTLY. DESPITE THIS, AN INJECTION WAS MADE, AND THE PATIENT FELT SOMETHING IN THE TOOTH DURING THE INJECTION. TREATMENT ON THE LEFT SIDE WAS STOPPED, AND THE OTHER SIDE WAS TREATED. THE PATIENT THEN EXPERIENCED "LIGHT-HEADEDNESS, NUMBNESS IN TOOTH, BECAME VISIBLY PALE, AND HAD SWEATING ON THE UPPER LIP. AFTER 15-20 MINUTES, PATIENT WAS FINE HOWEVER, A SPOT ON THE LEFT NASOLABIAL FOLD (NLF) CLOSE TO PIRIFORM AREA "TURNED DUSKY". TREATMENT INCLUDED A MIXTURE OF 1 VIAL OF HYLANEX (150 UNITS) WITH 3ML OF BACTERIOSTATIC SALINE WAS FLOODED OVER THE AFFECTED AREA AND MASSAGED THOROUGHLY WITH SILVER GEL. THE SPOT DID NOT DISAPPEAR COMPLETELY. EACH TIME THE AREA WAS MASSAGED, CAPILLARY REFILL IMPROVED, BUT IT WOULD WORSEN WHEN MASSAGING STOPPED. ALSO, RECOMMENDED A WARM COMPRESS. THE SKIN LOOKE

  Patient problems: Obstruction/Occlusion

  MAUDE report 22485629 ↗
• InjuryJul 1, 2025Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT PATIENT WAS INJECTED WITH ONE SYRINGE OF AN EXPIRED JUVÉDERM VOLBELLA® XC IN THE LIPS. APPROXIMATELY THREE WEEKS AFTER, THE PATIENT WAS SEEN FOR FOLLOW UP WITH NO COMPLAINTS. ABOUT TWO MONTHS POST INJECTIONS, THE PATIENT CALLED THE OFFICE STATING THEY WERE EXPERIENCING ¿BALLS ON MY UPPER AND LOWER LIP POSSIBLE GRANULOMAS AND PERSISTENT SWELLING.¿ THE FOLLOWING DAY THE PATIENT SAID THEIR LIPS ARE ¿NOW FELT HARD.¿ THE PATIENT WAS INSTRUCTED TO TAKE ¿BENADRYL OR ZYRTEK AND SUGGESTED THEM COME INTO THE OFFICE FOR A CONSULT WHICH PATIENT DECLINED.¿ FIVE DAYS LATER THE PATIENT REPORTED ¿I DRANK ALCOHOL LAST NIGHT AND WOKE UP THIS MORNING WITH MORE SWELLING AND WENT TO URGENT CARE AND WAS ADMINISTERED A STEROID INJECTION.¿ THE FOLLOWING DAY, THE PATIENT WENT TO ¿THE OFFICE WITH SWELLING TO UPPER AND LOWER LIP AND WAS PRESCRIBED PREDNISONE. HYLENEX® WAS ADMINISTERED (2CC'S ON TOP AND 2 CC'S ON BOTTOM) AS WELL AS A DECADRON INJECTION AND A IV DRIP OF MYERS COCKTAIL FOR IMMUNITY. TWO DAYS LATER, THE PATIENT STATED "SWELLING IS WORSE". SEVEN DAYS LATER, THE PATIENT WENT BACK TO THE OFFICE AND WAS ADMINISTERED HYLENEX® (1CC ON TOP LIP AND 1CC ON BOTT

  Patient problems: Inflammation

  MAUDE report 22370556 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ XC. PATIENT WAS PREVIOUSLY INJECTED WITH UNK DERMAL FILLER. AFTER THE INJECTION, PATIENT STARTED TO HAVE INTERMITTENT SWELLING IN THE AREA OF FILLER. PATIENT WAS TREATED WITH HYALURONIDASE AND STEROIDS (INJECTED AND ORAL) TO RESOLVE. PATIENT CONTINUE TO HAVE RECURRENT EPISODES OF SWELLING. SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER ABBVIE COMPLAINT (B)(4). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, UNK DERMAL FILLER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22014435 ↗
• InjuryMay 7, 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 JUVÉDERM VOLBELLA® XC AND JUVÉDERM VOLUMA® XC. HCP NOTES PATIENT CALLED TO INFORM THAT THEY THOUGHT THE FILLER TRAVELED. WHEN THE PATIENT CAME IN THERE WAS NO REDNESS, SWELLING, AND OR LUMPS FELT. THE PATIENT WAS NOT HAPPY WITH HOW IT LOOKED, AND THE HCP REQUESTED THAT THEY COULD DISSOLVE IT, BUT THE PATIENT DECLINED. ON THE NEXT DAY THE PATIENT CALLED THE OFFICE AFTER AN HOUR WITH EXTREME SWELLING TO INFORM THEM THAT THEY WENT TO THE ER AND WAS PRESCRIBED PREDNISONE AND ANTIBIOTICS AND WAS TOLD TO GET THE FILLER DISSOLVED. THE PATIENT WAS SEEN BY THE HCP TO SCHEDULE AN APPOINTMENT TO HAVE THE FILLER DISSOLVED BUT THE PATIENT CANCELLED THE APPOINTMENT. THE PATIENT STATED THAT IT WAS BETTER BUT STILL HAD POCKETS UNDER THEIR EYES. THE HCP RECOMMENDED THAT THEY HAVE LYMPHATIC MASSAGING. SO, ANOTHER FOLLOW-UP APPOINTMENT WAS SCHEDULED. ADDITIONALLY, THE HCP REPORTED THAT THE PATIENT WAS INJECTED WITH 2 ML OF JUVÉDERM VOLBELLA® XC IN THE INFRAORBITAL HOLLOW. THE INJECTION SITE WAS DIFFUSE. THE PATIENT EXPERIENCED SWELLING AT THE PERIORBITAL CHEEKS, AND THE PATIENT WAS SEEN IN THE ER. THERE WAS MEDICATION PROVIDED

  Patient problems: Inflammation

  MAUDE report 21981234 ↗
• InjuryApr 23, 2025Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE LIPS WITH 0.4ML OF JUVÉDERM® VOLBELLA® XC. TWENTY DAYS LATER, HCP REUSED THE SYRINGE AND INJECTED THE PATIENT WITH 0.6ML OF JUVÉDERM® VOLBELLA® XC IN THE LIPS. PATIENT BEGAN TO EXPERIENCE "VERY DELAYED NODULES" ABOUT 4 OR 5 MONTHS POST INJECTION. HCP LATER REPORTED THE PATIENT WAS PRESCRIBED VALTREX 1G BID X 7 DAYS FOR PRESENCE OF [NOT DEVICE RELATED] COLD SORE AND MEDROL DOSE PACK FOR INFLAMMATION THE SAME DAY AS SYMPTOM ONSET. ELEVEN DAYS LATER HCP INJECTED THE PATIENT WITH HYALURONIDASE 50U. THREE DAYS LATER HCP INJECTED THE PATIENT WITH HYALURONIDASE 65U. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 90U. PRESCRIBED THE PATIENT VALTREX 1G BID X 7 DAYS FOR THE [NOT DEVICE RELATED] COLD SORE. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 100U. PATIENT AGREED TO START TAKING PREDNISONE 30 MG X 3 DAYS, 20 MG X 2 DAYS, 10 MG X 2 DAYS. PATIENT DECLINED FURTHER TREATMENT, PREFERRING TO "ALLOW [THEIR] BODY TO NATURALLY METABOLIZE". SYMPTOMS ARE ONGOING. THIS RELATES TO THE REUSE OF THE SYRINGE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6). THIS EMDR

  Patient problems: Nodule

  MAUDE report 21893036 ↗
• InjuryApr 23, 2025Off-Label Use; Off-Label Use

  HEALTHCARE PROFESSIONAL HCP REPORTED INJECTING A PATIENT IN THE LIPS WITH 0.4ML OF JUVÉDERM® VOLBELLA® XC. TWENTY DAYS LATER, HCP REUSED THE SYRINGE AND INJECTED THE PATIENT WITH 0.6ML OF JUVÉDERM® VOLBELLA® XC IN THE LIPS. PATIENT BEGAN TO EXPERIENCE "VERY DELAYED NODULES" ABOUT 4 OR 5 MONTHS POST INJECTION. HCP LATER REPORTED THE PATIENT WAS PRESCRIBED VALTREX 1G BID X 7 DAYS FOR PRESENCE OF [NOT DEVICE RELATED] COLD SORE AND MEDROL DOSE PACK FOR INFLAMMATION THE SAME DAY AS SYMPTOM ONSET. ELEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 50U. THREE DAYS LATER HCP INJECTED THE PATIENT WITH HYALURONIDASE 65U. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 90U. PRESCRIBED THE PATIENT VALTREX 1G BID X 7 DAYS FOR THE [NOT DEVICE RELATED] COLD SORE. SEVEN DAYS LATER, HCP INJECTED THE PATIENT WITH HYALURONIDASE 100U. PATIENT AGREED TO START TAKING PREDNISONE 30 MG X 3 DAYS, 20 MG X 2 DAYS, 10 MG X 2 DAYS. PATIENT DECLINED FURTHER TREATMENT, PREFERRING TO "ALLOW [THEIR] BODY TO NATURALLY METABOLIZE". SYMPTOMS ARE ONGOING. THE PRODUCT WAS TRANSFERRED TO A TB SYRINGE PRIOR TO INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFI

  Patient problems: Nodule

  MAUDE report 21893035 ↗