BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 8784490 · Received July 12, 2019

    Report

    Report Number
    3005113652-2019-00553
    Event Type
    Injury
    Date Received
    July 12, 2019
    Report Date
    July 12, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: JUVÉDERM VOLLURE¿ XC. (B)(4). THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT'S FRIEND, WHO IS ALSO A HEALTHCARE PROFESSIONAL, REPORTED THAT THE PATIENT WAS INJECTED IN THE LIPS WITH 0.35 ML OF JUVÉDERM® ULTRA XC AND JUVÉDERM VOLBELLA® XC, IN THE MIDFACE WITH 1 ML OF JUVÉDERM VOLUMA® XC, AND IN THE NASOLABIAL FOLDS AND ORAL COMMISSURES WITH JUVÉDERM VOLLURE¿ XC. ¿4-6 WEEKS", ALSO DESCRIBED AS "1-2 MONTHS" LATER, THE PATIENT EXPERIENCED A LATE ONSET REACTION. THE PATIENT EXPERIENCED HARD NODULES OR WHAT MAY BE "GRANULOMAS" AND REDNESS AT ALL THE INJECTION SITES AND THE WHOLE FACE IS EXTREMELY SWOLLEN, WHICH IS EXTREMELY DISFIGURING. PATIENT'S FRIEND ADDED, "PATIENT DESCRIBES SWELLING, RAISED ENCAPSULATED NODULES UNDER THE SKIN, AND FIRMNESS AT INJECTION SITES. THERE WAS SOME ASSOCIATED TENDERNESS AT THE FIRST ONSET OF REACTION WHICH HAS NOW SUBSIDED TO ABOUT A 2/10. DENIES ERYTHEMA, WARMTH, AND DRAINAGE FROM THE AREAS.¿ A BIOPSY CONFIRMING THE ¿GRANULOMAS¿ HAS NOT BEEN PROVIDED. THE PATIENT HAS BEEN TREATED WITH HYLENEX 6 TIMES BY THE INJECTOR AND PRESCRIBED PREDNISONE BY THEIR PRIMARY CARE PHYSICIAN. EVERY TIME THE PATIENT IS TREATED WITH HYLENEX AND TAKES THE PREDNISONE THE SYMPTOMS START TO RESOLVE, BUT A FEW DAYS AFTER THE HYLENEX IS GIVEN OR IF THE PATIENT STOPS THE PREDNISONE, THE PATIENT¿S FACE BLOWS UP AND THE PATIENT IS UNRECOGNIZABLE. THE PATIENT'S FRIEND ADDED THAT THE HYLENEX "ALLEVIATES SOME OF THE LESIONS/SWELLING TEMPORARILY". "HOWEVER, WITHIN THE WEEK OF A HYLENEX TREATMENT, NEW NODULES OR AREAS OF SWELLING RE-APPEAR." THE PATIENT HAS BEEN TAKING THE PREDNISONE FOR OVER 45 DAYS; THIS HAS HELPED KEEP THE REACTION UNDER CONTROL SOMEWHAT, BUT IF PREDNISONE IS MISSED ONE DAY, THE FACE SWELLING IS SIGNIFICANT. "THE PATIENT IS A TYPE I DIABETIC AND THE LONG TERM USE OF THE PREDNISONE IS CAUSING THEIR SUGAR LEVELS TO BE HIGH WHICH IS DANGEROUS.¿ THE PATIENT'S FRIEND HAS NOT SEEN THE PATIENT AND HAS NOT CONFIRMED THE SYMPTOMS, BUT SAYS "THE EVENTS ARE PROBABLY NOT DUE TO THE FILLER BUT JUST HOW THE PATIENT IS REACTING TO THE FILLERS." THE PATIENT'S FRIEND ADDED, "IT SEEMS AS THOUGH [THE] BODY IS REJECTING THE HYALURONIC ACID" AND "[THE ISSUE] IS AFFECTING [THE PATIENT'S] QUALITY OF LIFE." THE SYMPTOM HAVE NOT RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00552 (ALLERGAN COMPLAINT # (B)(4)), MDR ID # 3005113652-2019-00554 (ALLERGAN COMPLAINT # (B)(4)), AND MDR ID # 3005113652-2019-00555 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM VOLUMA® XC, ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578520 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention JUVÉDERM® ULTRA XC, JUVÉDERM VOLBELLA® XC