BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 1091283 · Received July 31, 2008

    Report

    Report Number
    MW5007871
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    October 3, 2007
    Report Date
    July 31, 2008
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EIGHTEEN YEAR OLD SILICONE IMPLANTS REMOVED. IMPLANT WAS RUPTURED, AND SILICONE SPILLED THROUGH OUT MY CHEST. I AM EXTREMELY ILL. MY LIFE IS HELL AND I CANNOT BELIEVE THESE ARE ON THE MARKET. MY LIFE IS RUINED. SOMEDAY THE PEOPLE WHO ALLOWED THESE DEVICES WILL HAVE TO ANSWER TO A HIGHER POWER. I FEEL LIKE I AM DYING AND I MAY. AND I HAVE NO HELP IN PAYING FOR THIS. IMPLANTS WERE MENTOR. DO THESE PEOPLE HAVE NO SOUL? MY LIFE IS RUINED. THANKS. DOSE OR AMOUNT: ENOUGH TO KILL; FREQUENCY: EVERYDAY; ROUTE: OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR POISON, BREAST IMPLANTS FWM MENTOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention