BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINVIVE JUVEDERM

    MDR report key: 18573676 · Received January 23, 2024

    Report

    Report Number
    MW5150663
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    October 25, 2023
    Report Date
    January 19, 2024
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS INJECTED WITH A PRODUCT THAT WAS A DERMAL FILLER IN MY CHEEKS BY THE COMPANY JUVÉDERM/SKINVIVE ABOUT THREE WEEKS LATER MY SKIN AND THE INJECTED SITES WERE TURNING BROWNISH OR DARKER IN THE UPPER CHEEK AND LOWER CHEEK AND THEN IN BETWEEN WHERE IT WAS NOT INJECTED IT'S WHITE AND IT LOOKS LIKE ONE WHITE STRIPE WITH A TUNNEL. IT LOOKS LIKE A TUNNEL ON MY CHEEK. I FEEL THAT THIS PRODUCT DISFIGURED MY FACE. TO HELP MY SKIN, HAVE A BETTER GLOWING LOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474610 SKINVIVE JUVEDERM IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN SALES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other MULTIVITAMIN