BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA

    MDR report key: 19751351 · Received July 15, 2024

    Report

    Report Number
    MW5157303
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 11, 2024
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FOLLOWING RECEIVING JUVEDERM VOLUMNA JAW FILLER, I HAD A SEVERE INFLAMMATORY REACTION ON MY RIGHT JAWLINE AND CHEEK. I WAS PUT ON AN ANTIBIOTIC AND THREE WEEKS OF STEROIDS. AFTER COMPLETING THE TREATMENT, THE LEFT SIDE OF MY FACE MIRRORED THE SAME SEVERE INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748110 JUVEDERM VOLUMA IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN SALES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other BETA BLOCKER.| SLYND BIRTH CONTROL.| WELLBUTRIN.