BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY IMPLANT

    MDR report key: 1083251 · Received July 25, 2008

    Report

    Report Number
    MW5007810
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    November 4, 1986
    Report Date
    July 25, 2008
    Manufacturer
    SURGITEK - BRISTOL MYERS SQUIBB
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BREAST AUGMENTATION IN 1986. THEY USED SURGITEK MAMMARY IMPLANTS PRODUCT NO, 26250S LOT #41211-86-E. I JUST HAD AN MRI, AND THEY HAVE FOUND THAT THEY HAVE RUPTURED. I AM VERY WORRIED, I HAVE BEEN DOING A LOT READING ON SILICONE LEAKING IN THE BODY AND LAWSUITS REGARDING SURGITEK. I WOULD APPRECIATE ANY ADVICE OR INFO THAT YOU COULD GIVE ME. DATES OF USE: 1986 - 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY IMPLANT NONE FWM SURGITEK - BRISTOL MYERS SQUIBB PRODUCT# 26250S 41211-86-E

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening