JUVÉDERM VOLBELLA XC 95834Recalls & reported problems

Summary

The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 10888628032446), received between Dec 20, 2016 and May 4, 2022 — classified as 150 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Crack” (13 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 187 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  HEALTH PROFESSIONAL REPORTED IN THE ARTICLE ¿A RETROSPECTIVE REVIEW OF THE SAFETY AND EFFICACY OF LOW-DOSE TRIAMCINOLONE MIXED WITH HYALURONIC ACID FILLERS TO REDUCE POST-INJECTION INFRAORBITAL SWELLING¿ THAT 19 PATIENTS WERE INJECTED WITH JUVÉDERM VOLBELLA® XC AND SEVEN PATIENTS WITH JUVÉDERM® VOLLURE¿ XC EXPERIENCED SWELLING. ONE PATIENT INJECTED WITH JUVÉDERM VOLBELLA® XC EXPERIENCED ¿GRANULOMAS¿ THAT RESOLVED COMPLETELY WITHOUT FURTHER ADVERSE EVENTS ONCE THEY WERE INJECTED WITH HYALURONIDASE. BIOPSY WAS NOT PROVIDED.

  Patient problems: Nodule

  MAUDE report 14279430 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED IN THE ARTICLE ¿RADIAL SOUND (SHOCKWAVE) THERAPY RESOLVES DELAYED-ONSET NODULES FOLLOWING INJECTION OF HYALURONIC ACID DERMAL FILLER: A CASE STUDY¿ THAT A PATIENT WAS INJECTED IN THE CHEEKS AND MIDFACE WITH JUVÉDERM® VOLUMA¿ XC AND IN THE PERIORAL RHYTIDS WITH JUVÉDERM® VOLBELLA¿ XC. THREE MONTHS LATER, THE PATIENT EXPERIENCED ¿FIVE CIRCUMORAL NODULES¿ BILATERALLY IN THE ORAL COMMISSURES THAT WERE NOT VISIBLE BUT COULD BE DETECTED BY PALPATION. THE PATIENT REPORTED THAT THE NODULES FELT ¿HOT AND TIGHT¿ UNDER THE SKIN. THE PATIENT ALSO REPORTED TO HAVE EXPERIENCED A NON-DEVICE RELATED ¿UPPER RESPIRATORY INFECTION¿ TWO WEEKS BEFORE THE NODULES APPEARED, BUT WAS AFEBRILE UPON PRESENTATION, WITH NO SYSTEMIC SIGNS OF INFECTION; THUS, AN INFECTIOUS ETIOLOGY WAS NOT SUSPECTED REGARDING THE NODULES. THE PATIENT WAS TREATED WITH RADIAL SOUND TECHNOLOGY (RST), 80MJ/10HZ×2500 PULSES PER CHEEK AND 1,000 PULSES OVER THE UPPER LIP. IMMEDIATELY AFTER THE FIRST TREATMENT, LASTING 10 MINUTES, THE PATIENT STATED THAT THE NODULES FELT ¿LESS TIGHT¿ AND WERE ¿LESS HOT AND UNCOMFORTABLE.¿ IMMEDIATELY POST-PROCEDURE, THE NODULES FELT SMALLER AND SOFTER ON PALPATION. THE P

  Patient problems: Nodule; Respiratory Tract Infection

  MAUDE report 13955688 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTS LIP ANGIOEDEMA 4 YEAR POST TREATMENT WITH JUVÉDERM VOLBELLA® XC. NON-SEDATION ANTIHISTAMINE PROVIDED THE DAY SYMPTOM APPEARED. THE FOLLOWING DAY, SYMPTOMS RESOLVED.

  Patient problems: Angioedema

  MAUDE report 11476924 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LEFT TEAR TROUGH WITH 0.2 ML OF JUVÉDERM VOLBELLA® XC. FIVE MONTHS LATER, THE PATIENT WAS INJECTED BILATERALLY IN THE TEAR TROUGHS WITH 0.4 ML OF JUVÉDERM VOLBELLA® XC. SIX MONTHS LATER, THE PATIENT PRESENTED WITH ¿INDURATION AND FULLNESS¿ WHICH FURTHER SPECIFIED AS "FIRM, NON-TENDER, MILDLY ERYTHEMATOUS, MADLY EDEMATOUS AREA" IN THE INJECTION SITES. THAT DAY, THE PATIENT WAS TREATED WITH PREDNISONE THAT THEY DID NOT TAKE AND INSTEAD WENT TO SEE THEIR PRIMARY CARE PHYSICIAN. THE NEXT DAY, THE PATIENT WAS TREATED WITH A HYALURONIDASE/5FU/LIDOCAINE BLEND. ONE WEEK LATER, THE PATIENT REPORTED THAT THEY WERE DIAGNOSED WITH A "OTITIS MEDIA AND SINUSITIS," DEEMED NOT RELATED TO THE INJECTION, AND WAS TREATED WITH ANOTHER HYALURONIDASE/5FU/LIDOCAINE BLEND. ONE WEEK LATER, THE PATIENT REPORTED THAT THEY HAD "PNEUMONIA," DEEMED NOT RELATED TO THE INJECTION. THE PATIENT WAS TREATED WITH ANOTHER HYALURONIDASE/5FU/LIDOCAINE BLEND. THE EVENTS RESOLVED, WITH A "LESION" BEING REPORTED AS RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2020-00671 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTE

  Patient problems: Respiratory Tract Infection; Unspecified Infection

  MAUDE report 10795154 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LEFT TEAR TROUGH WITH .2 ML OF JUVÉDERM VOLBELLA® XC. FIVE MONTHS LATER, THE PATIENT WAS INJECTED BILATERALLY IN THE TEAR TROUGHS WITH .4 ML OF JUVÉDERM VOLBELLA® XC. SIX MONTHS LATER, THE PATIENT PRESENTED WITH ¿INDURATION AND FULLNESS¿ IN THE INJECTION SITES, NOTED AS "FIRM, NON-TENDER, MILDLY ERYTHEMATOUS, MADLY EDEMATOUS AREA." THAT DAY, THE PATIENT WAS TREATED WITH PREDNISONE THAT THEY DID NOT TAKE AND INSTEAD WENT TO SEE THEIR PRIMARY CARE PHYSICIAN. THE NEXT DAY, THE PATIENT WAS TREATED WITH A HYALURONIDASE / 5FU / LIDOCAINE BLEND. ONE WEEK LATER, THE PATIENT REPORTED THAT THEY WERE DIAGNOSED WITH A "SINUS INFECTION" AND WAS TREATED WITH ANOTHER HYALURONIDASE / 5FU / LIDOCAINE BLEND. ONE WEEK LATER, THE PATIENT REPORTED THAT THEY HAD "PNEUMONIA." THE PATIENT WAS TREATED WITH ANOTHER HYALURONIDASE/5FU/LIDOCAINE BLEND. THE EVENT RESOLVED, WITH A "LESION" BEING REPORTED AS RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID#: 3005113652-2020-00642 (ALLERGAN COMPLAINT#: (B)(4). THIS MDR IS BEING SUBMITTED FOR THE SECOND INJECTION OF SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

  Patient problems: Unspecified Infection

  MAUDE report 10792920 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED WITH 2 SYRINGES OF JUVÉDERM® ULTRA XC IN THE MARIONETTES AND LIPS AND 1 SYRINGE OF JUVÉDERM VOLBELLA® XC IN THE LIPS. ABOUT 4 WEEKS, LATER, THE PATIENT CAME BACK TO THE OFFICE AND WAS INJECTED WITH ANOTHER SYRINGE OF JUVÉDERM VOLBELLA® XC ABOVE THE LIPS. ABOUT 3 YEARS LATER, PATIENT CONTACTED THE HCP AND REPORTED THEY DEVELOPED "SOME SORT OF GROWTH" IN THEIR LIP AND IT HAD TO BE SURGICALLY REMOVED. HCP CONFIRMED THIS SURGERY HAPPENED OUTSIDE OF THEIR CLINIC AND DID NOT HAVE ANY OTHER DETAILS. THE PATIENT INDICATED THE SURGEON STATED THE "GROWTH" COULD HAVE BEEN DUE TO THE FILLER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00780 (ALLERGAN COMPLAINT #2016226) AND MDR ID # 3005113652-2019-00781 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND INJECTION OF JUVÉDERM VOLBELLA® XC.

  Patient problems: Skin Irritation

  MAUDE report 9291129 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED WITH 2 SYRINGES OF JUVÉDERM® ULTRA XC IN THE MARIONETTES AND LIPS AND 1 SYRINGE OF JUVÉDERM VOLBELLA® XC IN THE LIPS. ABOUT 4 WEEKS, LATER, THE PATIENT CAME BACK TO THE OFFICE AND WAS INJECTED WITH ANOTHER SYRINGE OF JUVÉDERM VOLBELLA® XC ABOVE THE LIPS. ABOUT 3 YEARS LATER, PATIENT CONTACTED THE HCP AND REPORTED THEY DEVELOPED "SOME SORT OF GROWTH" IN THEIR LIP AND IT HAD TO BE SURGICALLY REMOVED. HCP CONFIRMED THIS SURGERY HAPPENED OUTSIDE OF THEIR CLINIC AND DID NOT HAVE ANY OTHER DETAILS. THE PATIENT INDICATED THE SURGEON STATED THE "GROWTH" COULD HAVE BEEN DUE TO THE FILLER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00780 (ALLERGAN COMPLAINT #2016226) AND MDR ID #3005113652-2019-00782 (ALLERGAN COMPLAINT #2016232). THIS MDR IS BEING SUBMITTED FOR THE FIRST INJECTION OF JUVÉDERM VOLBELLA® XC.

  Patient problems: Skin Irritation

  MAUDE report 9291087 ↗
• InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY, THE HEALTHCARE PROFESSIONAL (HCP) CLARIFIED THAT THE HARD LUMPS WITH ERYTHEMA WERE FIRST DEVELOPED TO THE RIGHT MEDIAL TEAR TROUGH, THEN BILATERAL TEAR THROUGHS. THE MRI PERFORMED ALSO SHOWED A MILD PARANASAL SINUS DISEASE WITHOUT AN AIR-FLUID LEVEL. THE MASS LESIONS IN THE RIGHT WERE GREATER THAN THE LEFT INFRAORBITAL REGION. WHEN TALKING ABOUT THE PATIENT¿S HISTORY, THE HCP NOTED THAT THE PATIENT GETS FREQUENT SINUS INFECTIONS. OVER 2 WEEKS FROM THE DOXYCYCLINE 100 MG TWICE A DAY FOR 2 WEEKS TREATMENT, THE PATIENT FOLLOWED UP WITH THE HCP FOR THE DELAYED INFLAMMATORY NODULES. AT THAT TIME THE PATIENT FELT THAT SWELLING IN THE LIPS HAD SETTLED DOWN AND HAD NOT DEVELOPED REDNESS. PALPABLE NODULES WERE STILL PRESENT IN THE RIGHT AND LEFT MALAR REGIONS, BUT THE LEFT ORBITAL RIM NODULE SEEMED TO HAVE RESOLVED. RIGHT UPPER LIP HAD SWELLING BUT LEFT UPPER SIDE LOOKED BETTER. HCP DID NOT FEEL MUCH AT THE TOP OF THE NASOLABIAL FOLD. PATIENT CONTINUED ON ANOTHER 2-WEEK COURSE OF DOXYCYCLINE 100MG BID. THE PATIENT WAS OFFERED HYALURONIDASE TO DISSOLVE, BUT THE PATIENT DID NOT WANT TO LOSE THE VOLUME AND DECLINED. 2 DAYS AFTER THIS, THE PATIENT UNDERWENT SHOULDER SURGERY. OVER

  Patient problems: Inflammation; Pain; Skin Irritation

  MAUDE report 9173330 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY, THE HEALTHCARE PROFESSIONAL CLARIFIED THAT THE JUVÉDERM® VOLBELLA® XC WAS ONLY INJECTED UNDER THE EYE, NOT THE LAUGH LINES OR PERIORAL LINES. THE JUVÉDERM® VOLLURE® XC WAS NOT INJECTED IN THE UNDEREYE AREA; THIS PRODUCT WAS INJECTED IN THE GLABELLA, LAUGH LINES, AND PERIORAL LINES.

  Patient problems: Edema; Hypersensitivity/Allergic reaction

  MAUDE report 8802649 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED ¿INFLAMMATORY NODULE, SOME VISIBLE¿ ON THEIR LOWER RIGHT JAW, ABOVE/UPPER LIPS AND MARIONETTE REGION, 6 MONTHS AFTER INJECTION WITH ONE SYRINGE OF JUVÉDERM VOLBELLA® XC. TREATMENT IS NOTED AS CIPROFLOXACIN, DOXYCYCLINE, PREDNISONE, AND HYLENEX. TWO WEEKS AFTER FILLER PATIENT HAD A HEART ATTACK. PATIENT HAD SHINGLES, A SINUS AND EAR INFECTION FOUR MONTHS AFTER INJECTION, LASTING FOR 3 MONTHS; THESE WERE DETERMINED TO NOT BE DEVICE RELATED. EVENTS ARE ONGOING AT THIS TIME. PATIENT WAS CONCOMITANTLY INJECTED WITH 2 SYRINGES OF JUVÉDERM VOLLURE¿ XC. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00535 (ALLERGAN (B)(4)). THIS MDR IS BEING SUBMITTED FOR JUVÉDERM VOLBELLA® XC.

  Patient problems: Inflammation; Skin Irritation

  MAUDE report 8782575 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED 3 DAYS AFTER INJECTION WITH 0.55 CC JUVÉDERM VOLBELLA® XC INTO THE LIPS, THE PATIENT DEVELOPED ¿UPPER LIP DEVELOPED SWELLING¿ AND ¿SIGNIFICANT SWELLING, EDEMA, MULTIPLE SMALL NODULES ALONG SITES OF INJECTION.¿ NINE DAYS AFTER SYMPTOMS BEGAN THE PATIENT WAS TREATED WITH HYALURONIDASE, AND 9 DAYS LATER WITH HYALURONIDASE & LORATADINE. SYMPTOMS ARE ONGOING.

  Patient problems: Edema; Skin Irritation

  MAUDE report 8708299 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LIPS WITH .55CC OF JUVÉDERM VOLBELLA® XC. THE PATIENT HAD ¿SWELLING AND FIRM LUMPS AT ALL AREAS OF FILLER PLACEMENT¿ 8.5 MONTHS LATER. THE PATIENT WAS TREATED WITH HYALURONIDASE HALF A MONTH LATER, AGAIN 2 DAYS LATER, AND ONCE MORE 5 DAYS LATER. THE PATIENT IS TAKING PREDNISONE 20 MG BID AND BENADRYL "TO KEEP SWELLING AT BAY.¿

  Patient problems: Edema; Skin Irritation

  MAUDE report 8708249 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED TO HAVE INJECTED A PATIENT IN THE LIPS WITH JUVÉDERM® VOLBELLA® XC. OVER 2 MONTHS LATER, THE PATIENT DEVELOPED "GRANULOMAS" AT THE INJECTED AREAS. THE "GRANULOMAS" HAVE NOT BEEN CONFIRMED WITH A BIOPSY. 5 DAYS LATER, THE PATIENT WAS TREATED WITH PREDNISONE. A WEEK LATER, THE PATIENT WAS TREATED WITH HYLENEX® AND "SOME RESOLUTION WAS MADE BUT NOT COMPLETE." ALMOST THREE WEEKS LATER, THE PATIENT WAS TREATED WITH HYLENEX® ONCE MORE. THE SYMPTOMS HAVE NOT RESOLVED. THE EVENT HAS NOT LED TO PERMANENT DAMAGE.

  Patient problems: Inflammation; Skin Irritation

  MAUDE report 8527669 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 2 CC OF JUVÉDERM VOLUMA® XC, 1CC OF JUVÉDERM VOLLURE¿ XC, AND JUVÉDERM® ULTRA PLUS XC. APPROXIMATELY 10 MONTHS LATER, PATIENT WAS INJECTED WITH 0.55 CC OF JUVÉDERM VOLBELLA® XC AND RADIESSE. INJECTION SITES WERE REPORTED AS ¿CHEEKS, MARIONETTE FOLDS, AND UPPER PERIORAL RHYTIDS,¿ HOWEVER, THE SPECIFIC SITES WERE NOT GIVEN FOR EACH PRODUCT. ABOUT 9 MONTHS LATER, PATIENT EXPERIENCED FULL FACE EDEMA, "NODULES, PAIN, TENDERNESS.¿ HCP REPORTED ¿SYMPTOMS WORSENED WITH FURTHER NODULE FORMATION AT SPECIFIC SITES OF VYCROSS FILLERS.¿ SWELLING BEGAN AFTER BEING INJECTED WITH XEOMIN. TREATMENT IS NOTED AS ¿PREDNISONE, BACTRIM, VALTREX, ZYRTEC¿, ¿HYDROXYZINE, CLARITHROMYCIN¿, AND "HYALURONIDASE." EVENT IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00295 (ALLERGAN (B)(4)), MDR ID # 3005113652-2019-00294 (ALLERGAN (B)(4)), AND MDR ID # 3005113652-2019-00337 (ALLERGAN (B)(4)). THIS MDR IS BEING SUBMITTED FOR JUVÉDERM VOLBELLA® XC.

  Patient problems: Edema; Pain; Skin Irritation

  MAUDE report 8518585 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE GLABELLA WITH 1 SYRINGE OF JUVÉDERM VOLBELLA® XC. THREE MONTHS LATER, THE PATIENT WAS INJECTED IN THE MARIONETTE LINES WITH 1 SYRINGE OF JUVÉDERM VOLBELLA® XC. TWO AND A HALF MONTHS LATER, THE PATIENT PRESENTED WITH ¿SWELLING AND ERYTHEMA¿ AT THE INJECTION SITE. THE PATIENT WAS TREATED THE SAME DAY WITH PREDNISONE, BIAXIN 500 MG BID X 30 DAYS, AND HYLENEX. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID 3005113652-2019-00284 (ALLERGAN PR (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND INJECTION OF SUSPECTED PRODUCT, JUVÉDERM VOLBELLA® XC V15LA70557.

  Patient problems: Edema; Erythema

  MAUDE report 8517822 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE GLABELLA WITH 1 SYRINGE OF JUVÉDERM VOLBELLA® XC. THREE MONTHS LATER, THE PATIENT WAS INJECTED IN THE MARIONETTE LINES WITH 1 SYRINGE OF JUVÉDERM VOLBELLA® XC. TWO AND A HALF MONTHS LATER, THE PATIENT PRESENTED WITH ¿SWELLING AND ERYTHEMA¿ AT THE INJECTION SITE. THE PATIENT WAS TREATED THE SAME DAY WITH PREDNISONE, BIAXIN 500 MG BID X 30 DAYS, AND HYLENEX. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID 3005113652-2019-00290 (ALLERGAN PR (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST INJECTION OF SUSPECTED PRODUCT, JUVÉDERM VOLBELLA® XC V15LA70557.

  Patient problems: Edema; Erythema

  MAUDE report 8517818 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION WITH .55 OF JUVÉDERM VOLBELLA® XC IN THE LIPS AND RHYTIDS, THE PATIENT EXPERIENCED "SWELLING, FIRM, ERYTHEMA, AND WARMTH NODULAR AT INJECTION SITE" THREE AND A HALF MONTHS LATER. THE INJECTOR WROTE, "I DO FEEL THIS IS TRULY A DELAYED ONSET ALLERGIC REACTION." THE DAY SYMPTOMS BEGAN THE PATIENT WAS TREATED WITH HYLENEX INJECTION AND ORAL STEROIDS. THE PATIENT HAD 3 ADDITIONAL INJECTIONS OF HYLENEX AS TREATMENT. SYMPTOMS ARE ONGOING.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Skin Irritation

  MAUDE report 8505569 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED ABOUT 6 MONTHS AFTER INJECTION IN THE LIPS WITH 1 SYRINGE JUVÉDERM VOLBELLA® XC THE PATIENT EXPERIENCED ¿DELAYED ONSET NODULES.¿ THE PATIENT HAS A "DISFIGURING LARGE NODULE ON THE LOWER LIP AND MULTIPLE NODULES ON THE UPPER LIP THAT ARE NON TENDER." 13 DAYS AFTER SYMPTOMS BEGAN THE PATIENT WAS TREATED WITH BIAXIN AND THEN MEDROL DOSE PACK. SYMPTOMS ARE ONGOING.

  Patient problems: Skin Irritation

  MAUDE report 8496457 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED TO HAVE INJECTED A PATIENT IN THE LIPS AND ABOVE THE LIPS WITH JUVÉDERM® VOLBELLA® XC. ABOUT 4 MONTHS LATER, THE PATIENT EXPERIENCED ¿TENDER, NON-ERYTH. NODULES ABOVE LIPS AND UPPER LIPS.¿ ABOUT A WEEK LATER, THE PATIENT WAS TREATED WITH BENADRYL® AND HYALURONIDASE. ABOUT A WEEK AND A HALF LATER, THE PATIENT EXPERIENCED NEW NODULES IN THE LOWER LIPS. THE PATIENT WAS TREATED WITH KENALOG AND HYALURONIDASE ON THE SAME DAY. THE PATIENT WAS TREATED 3 ADDITIONAL TIMES WITH KENALOG AND HYALURONIDASE WITHIN A WEEK. THE SYMPTOMS HAVE NEARLY RESOLVED.

  Patient problems: Pain; Skin Irritation

  MAUDE report 8397021 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED TO HAVE INJECTED A PATIENT WITH 3 SYRINGES OF JUVÉDERM® VOLUMA® XC IN THE CHEEKS, 1 SYRINGE OF JUVÉDERM® VOLBELLA® XC IN THE LIPS, AND 1 SYRINGE OF JUVÉDERM® VOLLURE® XC IN THE NASOLABIAL FOLDS. ALMOST 5 MONTHS AFTER INJECTION, THE PATIENT BEGAN TO EXPERIENCE BUMPS AND NODULES AT THE INJECTION SITES. THE PATIENT HAS BEEN INJECTED BY ANOTHER HEALTHCARE PROFESSIONAL WITH VITRASE® 150 MG 2 TIMES, TWO WEEKS APART. VITRASE® WAS INJECTED TO THE LIP NODULES THAT WERE UNCOMFORTABLE AND PAINFUL TO EAT AS WELL AS CHANGING THE PATIENT¿S SMILE, TO THE MARIONETTES, AND TO THE CHIN AREA. THE HEALTHCARE PROFESSIONAL FURTHER NOTED THAT THE VITRASE® TREATMENT INTO THE NODULES OCCURRED ¿WITH DIFFICULTY¿. THE PATIENT WAS ALSO TREATED WITH STEROIDS X2. THE SYMPTOMS HAVE RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00162 (ALLERGAN COMPLAINT # (B)(4)) AND MDR ID # 3005113652-2019-00164 (ALLERGAN COMPLAINT # (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLBELLA® XC.

  Patient problems: Pain; Skin Irritation

  MAUDE report 8363413 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1CC OF JUVÉDERM® ULTRA PLUS IN THE LIPS; 13 DAYS LATER, PATIENT WAS INJECTED WITH 1CC OF JUVÉDERM VOLBELLA® XC IN THE TEAR TROUGHS. DURING THE VOLBELLA® XC INJECTION, THE PATIENT WAS CONCOMITANTLY INJECTED WITH JUVÉDERM VOLUMA® XC IN THE CHEEKS, BUT NO ISSUES HAVE BEEN REPORTED RELATING TO THE CHEEK INJECTION. ABOUT 2 MONTHS LATER, THE PATIENT EXPERIENCED SWELLING IN BOTH TEAR TROUGHS. PATIENT ALSO EXPERIENCED ANGIOEDEMA AND SWELLING IN THE LIPS THAT WOULD INITIALLY PRESENT IN THE MORNING, THEN SUBSIDE DURING THE DAY. TWO WEEKS LATER, THE PATIENT WAS TREATED WITH AN ANTIHISTAMINE AND POSSIBLY VITRASE. HEALTHCARE PROFESSIONAL INDICATED THE SYMPTOMS RELATED TO JUVÉDERM VOLBELLA® XC RESOLVED. EIGHT DAYS LATER, THE PATIENT¿S LIPS BECAME ¿LUMPY/BUMPY.¿ PATIENT WAS TREATED WITH VITRASE IN THE LIPS AND RECEIVED ORAL PREDNISONE, XYZAL, AND BENADRYL AS TREATMENT. IT WAS NOTED THAT THE HARDENING OF THE LIPS WAS RESOLVING. THE NEXT DAY THE PATIENT CLAIMED THEY SUFFERED FROM DIFFICULTY BREATHING. SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2019-00200 (ALLERGAN COMPLAINT # (B)(4)).

  Patient problems: Edema

  MAUDE report 8358946 ↗
• InjuryFeb 19, 2019Adverse 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 0.55 CC JUVÉDERM VOLBELLA® XC. THE PATIENT WAS CONCOMITANTLY INJECTED WITH RADIESSE IN THE ORAL COMMISSURES. FOUR AND A HALF MONTHS LATER, THE PATIENT REPORTED SMALL NODULES IN THE LIPS. ELEVEN DAYS LATER, THE NODULE POSSIBLY INCREASED IN SIZE. THE NEXT MONTH, THE PATIENT ALSO EXPERIENCED PNEUMONIA AND SINUS INFECTIONS AND HAD DENTAL PROCEDURES. THE INJECTOR LATER CONFIRMED TREATING THE PATIENT 11 DAYS AFTER THE SYMPTOMS APPEARED WITH PREDNISONE AND BIAXIN, AND REPEATED THE TREATMENT PLAN ABOUT ONE MONTH LATER. SYMPTOMS HAVE NOT RESOLVED.

  Patient problems: Skin Irritation

  MAUDE report 8351298 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN AN UNSPECIFIED SITE WITH AN UNSPECIFIED AMOUNT OF JUVÉDERM VOLBELLA® XC. AT AN UNSPECIFIED TIME LATER, THE PATIENT EXPERIENCED ¿DELAYED NODULES.¿ NO OTHER INFORMATION WAS PROVIDED. THE INJECTOR LATER CONFIRMED INJECTING THE PATIENT IN THE VERMILLION, LIPS, MARIONETTE LINES, AND UPPER LIP LINE WITH .5 CC OF JUVÉDERM VOLBELLA® XC. THE SYMPTOMS FIRST APPEARED 8.5 MONTHS LATER WITH ¿ERYTHEMATOUS TENDER NODULES AT THE INJECTION SITES.¿ THE PATIENT WAS TREATED 2 DAYS LATER WITH INTRALESIONAL KENALOG, PREDNISONE, AND DOXYCYCLINE. THE PATIENT WAS THEN TREATED A WEEK LATER WITH ¿ILK¿ AND DOXYCYCLINE. THE PATIENT WAS THEN TREATED WITH HYLENEX AND DOXYCYCLINE 6 DAYS LATER, AGAIN 6 DAYS LATER, AND ONCE MORE 8 DAYS LATER.

  Patient problems: Pain; Skin Irritation

  MAUDE report 8278266 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED THAT THE SYMPTOMS RESOLVED ABOUT TWO MONTHS AFTER THE DATE OF ONSET.

  Patient problems: Edema; Skin Irritation

  MAUDE report 8258767 ↗
• MalfunctionJan 3, 2019Crack; Gel Leak; Detachment of Device or Device Component; Crack; Gel Leak; Detachment of Device or Device Component

  HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 SYRINGE OF JUVÉDERM VOLBELLA® XC IN THE FINE LINES AROUND THE MOUTH. WHEN THEY SWITCHED TO THE SECOND NEEDLE, THEY "TWISTED IT ON REALLY GOOD AND HAD A CRACK AT THE LUER LOCK." THEY WENT TO INJECT AND THE NEEDLE DISENGAGED. THE FILLER WENT ALL OVER THE PATIENT AND THE NEEDLE STUCK IN THE PATIENT. NO INJURY TO THE PATIENT OR INJECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8213150 ↗