BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE TESTICLE

    MDR report key: 859224 · Received May 24, 2007

    Report

    Report Number
    MW5002099
    Event Type
    Injury
    Date Received
    May 24, 2007
    Date of Event
    May 1, 2007
    Report Date
    May 24, 2007
    Product Code
    FAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HUSBAND IMPLANTED IN EARLY 90'S WITH RIGHT SILICONE TESTICLE. IT RUPTURED IN 2007. LOOKS LIKE IT HAD BEEN LEAKING OVER A PERIOD OF TIME PER HIS DR REPORTS. HAD TO HAVE SURGERY TO HAVE IT REMOVED. I STARTED DOING RESEARCH AND FOUND THERE WAS A RECALL. I AM ALSO WONDERING IF THIS COULD BE WHAT HAS MADE ME SICK WITH WHAT I THINK MY HUSBAND HAS, SILICONE IMPLANT DISEASE. MY HUSBAND AND I WOULD BE WILLING TO UNDERGO AND TEST TO SEE IF YOU COULD HELP US WITH OUR HEALTH ISSUES. WE WERE NEVER INFORMED OF THE RECALL BY ANYONE. ANY INFO WOULD BE APPRECIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE TESTICLE FAF

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| O| R