BEUDAMED
    FDA Adverse Event Summary report: N

    SILASTIC MAMMARY PROSTHESIS

    MDR report key: 13318 · Received May 18, 1994

    Report

    Report Number
    MW1002052
    Date Received
    May 18, 1994
    Date of Event
    November 2, 1981
    Report Date
    May 11, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF RASHES, SCALY SKIN, BLISTERS ON HANDS AND ARMS, BURNING PAIN IN CHEST, DRY EYES, MOUTH, AND VAGINA, HANDS TURN WHITE IN COLD WEATHER, JOINT SWELLING AND TENDERNESS, ENLARGED LYMPH NODES, MUSCLE ACHES, PAIN AND WEAKNESS, LOSS OF MEMORY, LOSS OF SALARY, PHOTOSENSITIVITY, SLEEP DISTURBANCE, CHRONIC FATIGUE, NIGHT SWEATS, LOW GRADE FEVERS, EYE PROBLEMS, AND TINGLING IN LEGS AND ARMS. (SEE ALSO 1002051 AND 1002053.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY PROSTHESIS Implant FTR DOW CORNING CORP. H080965

    Patients

    Seq Age Sex Outcome Treatment
    1 *