BEUDAMED
    FDA Adverse Event Summary report: N

    SILASTIC BREAST IMPLANT

    MDR report key: 13995 · Received June 14, 1994

    Report

    Report Number
    MW1002464
    Date Received
    June 14, 1994
    Report Date
    June 10, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAS EXPERIENCED AN INFECTED LEFT IMPLANT, CIRCULATORY PROBLEMS, GOUT, HIGH BLOOD PRESSURE, IMPLANT LEAKAGE, CAPSULAR CONTRACTURE, ARTHRITIS SYMPTOMS IN HANDS, SHOULDERS, BACK AND WRISTS, JOINT SWELLING IN ANKLES, HANDS, FINGERS AND KNOTS, HARDENING OF SKIN AROUND IMPLANT, MUSCLE FATIGUE OF BACK (WORSE WHEN DAMP), SWELLING HANDS AND FINGERS, RASHES ON CHEST, BREAST AND FINGERS, BREAST TENDERNESS, NO SEX DRIVE, SWOLLEN GLANDS IN NECK, MEMORY PROBLEM, SLEEP PROBLEMS, WEIGHT GAIN, EXTREMELY COLD BREASTS, INCORRECT SIZE OF IMPLANTS, MALPOSITION OF IMPLANTS, WRINKLES, HARDNESS, INABILITY TO LIE ON STOMACH, BACKACHES, ARM WEAKNESS, DEPRESSION, AND DIFFICULTY LIFTING. (SAME RPTR REFERRED TO IN 1002465.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC BREAST IMPLANT FTR DOW CORNING CORP. HH 0315

    Patients

    Seq Age Sex Outcome Treatment
    1 *