BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 125246 · Received October 2, 1997

    Report

    Report Number
    MW1012258
    Date Received
    October 2, 1997
    Date of Event
    January 1, 1971
    Report Date
    September 30, 1997
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 1971 DR. IMPLANTED PT WITH DOW CHEMICAL IMPLANTS. IMMEDIATELY PT STARTED HAVING ALL KINDS OF PROBLEMS HARDNESS OF BREASTS, INFECTION ON 9/26/79. DR. REMOVED BOTH DOW IMPLANTS AND REPLACED THEM WITH ANOTHER CO'S. 1980 IMPLANT RUPTURED AND LEFT HOLE IN RIGHT BREAST THE SIZE OF A HALF DOLLAR. IMPLANT WAS REMOVED. AS A RESULT OF THE IMPLANTS RPTR HAS SUFFERED EXTREME MENTAL AND EMOTIONAL ANGUISH AS WELL AS EXCRUCIATING PAIN. RPTR HAS SUFFERED MEMORY LOSS, AS WELL AS THE LOSS OF THOUSANDS OF DOLLARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant * FWM DOW CORNING CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR