BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 553177 · Received August 17, 2004

    Report

    Report Number
    MW1032962
    Event Type
    Injury
    Date Received
    August 17, 2004
    Date of Event
    May 20, 2004
    Report Date
    August 17, 2004
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD RESTYLANE INJECTIONS FOR WRINKLES BELOW MOUTH. THEY THOUGHT PROCEDURE WENT WELL UNTIL LATER, WHEN THEY DISCOVERED THAT THE SOLUTION HAD SETTLED BELOW THE WRINKLES INTO CHIN AREA. WRINKLES STILL REMAINED THE SAME, BUT THE RESTYLANE HAS SETTLED INTO POCKETS AND CLUMPS IN CHIN AREA, WHICH COULD REMAIN THERE UP TO A YEAR. MEDICIS AESTHETICS HAS BEEN EVASIVE AND UNHELPFUL WHEN PT HAS SOUGHT ANSWERS AND ADVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RESTYLANE LMH MEDICIS AESTHETICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR