BEUDAMED
    FDA Adverse Event Summary report: N

    SILASTIC MAMMARY IMPLANT, 150 CC

    MDR report key: 17501 · Received November 2, 1994

    Report

    Report Number
    MW1003955
    Date Received
    November 2, 1994
    Report Date
    November 2, 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

    BREAST PAIN AFTER IMPLANTS, STOMACH, COLON AND EAR PROBLEMS, MENIERE'S DISEASE, LOW BLOOD PRESSURE, FIBROCYSTIC BREASTS, RASHES, LEAKING IMPLANTS, FATIGUE, SWELLING OF HANDS AND FINGERS, MUSCLE FATIGUE, ARTHRALGIAS, GENERAL ACHING/STIFFNESS, LEFT IMPLANT LOOKS LIKE IT IS UNDER ARM, SICCA SYMPTOMS, RAYNAUD'S, FEVER, CHILLS, BOWEL IRRITABILITY, BALANCE DISTURBANCES, DIFFICULTY SWALLOWING, NON-SPECIFIC GASTRITIS. ALSO SEE 1003956.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY IMPLANT, 150 CC Implant FTR DOW CORNING CORP. HH044853

    Patients

    Seq Age Sex Outcome Treatment
    1 *