BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTYLANE FILLER

    MDR report key: 8186030 · Received December 19, 2018

    Report

    Report Number
    MW5082349
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 16, 2018
    Report Date
    December 18, 2018
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A COUPLE OF INJECTIONS OF RESTYLANE FILLER UNDER THE EYE AND OVER THE COURSE OF A FEW MONTHS DEVELOPED BAGS OF FLUID AND INFLAMMATION. I HAVE BEEN RETURNING TO THE SAME INJECTOR FOR A DISVANT, THIS HAS HELPED BUT I WILL LIKELY HAVE PERMANENT PUDDLES UNDER MY EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021456 RESTYLANE FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other