BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLBELLA

    MDR report key: 7402277 · Received April 5, 2018

    Report

    Report Number
    MW5076359
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    October 15, 2017
    Report Date
    April 3, 2018
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GRANULOMA FORMATION. HAD VOLBELLA FILLER INJECTED INTO MY PERIORAL LINES IN (B)(6) 2017; IN EARLY (B)(6) 2017, I DEVELOPED 4 HARD LUMPS IN MY FACE. THREE WERE ON MY EYE SOCKET BONES; 1 NEXT TO MY MOUTH. I WENT TO A DERMATOLOGIST FOR ANSWERS; WAS REFERRED TO A FACIAL PLASTIC SURGEON TO EXCISE ONE LUMP TO DETERMINE THE TYPE; IT WAS DIAGNOSED AS A GRANULOMA. FURTHER ANALYSIS SHOWED HYALURONIC FILLER AT THE CENTER OF THE MASS. I WAS TREATED WITH ORAL STEROIDS FOR 3 WEEKS, AND HAVE BEEN TAKING DOXYCYCLINE, 500 ML, ONCE DAILY SINCE. ALL THE LUMPS HAVE RESOLVED, EXCEPT FOR THE ONE NEXT TO MY MOUTH, WHICH IS NOT VISIBLE, BUT CAN BE FELT. I HAVE HAD RESTYLANE SILK, JUVEDERM XC, AND VOLUMA PREVIOUSLY OVER 7 YEARS, WITH NO REACTIONS. THE VYCROSS TECHNOLOGY APPEARS TO BE WHAT TRIGGERED THE GRANULOMATIC RESPONSE. HOW WAS IT TAKEN OR USED: SUBCUTANEOUS. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2017. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2017. WHY WAS THE PERSON USING THE PRODUCT: PERIORAL LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244531 JUVEDERM VOLBELLA IMPLANT DERMAL LMH ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other