BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 1052217 · Received May 24, 2008

    Report

    Report Number
    MW5007038
    Event Type
    Injury
    Date Received
    May 24, 2008
    Date of Event
    May 14, 2007
    Report Date
    May 24, 2008
    Manufacturer
    MENTOR
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I RECEIVED MENTOR SILICONE GEL BREAST IMPLANTS. I RECEIVED THE "GUMMY BEAR" IMPLANTS AND AM NOT IN ANY STUDY NOR TOLD I HAD TO BE IN A STUDY OR A CERTAIN AGE TO GET THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SILICONE GEL "GUMMY BEAR" IMPLANTS FTR MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other| S