BEUDAMED
    FDA Adverse Event Summary report: N

    BREAST IMPLANT, 175 CC

    MDR report key: 11224 · Received February 2, 1994

    Report

    Report Number
    MW1000595
    Date Received
    February 2, 1994
    Report Date
    January 26, 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

    ON 4/28/75, RPTR HAD A SIMPLE MASTECTOMY WITH BILATERAL AUGMENTATION MAMMOPLASTY FOR FIBROCYSTIC DISEASE. THIS CO'S IMPLANT WAS USED. ON 6/25/82, RPTR HAD REMOVAL AND REPLACEMENT WITH ANOTHER CO'S IMPLANTS BECAUSE OF SEVERE BILATERAL CAPSULAR CONTRACTURE. OTHER PROBLEMS: POOR CIRCULATION, PAIN IN BREASTS, BACK, RIBS, ARMS AND FINGERS, POSSIBLE IMPLANT LEAKAGE/RUPTURE, ARTHRITIS, RHEUMATOID ARTHRITIS, RASHES ON ARMS, FATIGUE, JOINT SWELLING/PAIN/STIFFNESS, MUSCLE FATIGUE, IMPLANT SKIN HARDENING, FINGER AND HAND SWELLING, GLANDS UNDER ARMS SWELL, HAIR LOSS, COLDNESS AND PAIN OF EXTREMITIES, SECOND IMPLANTS DON'T FEEL RIGHT, HIP REPLACED, GASTRITIS, DEGENERATION OF CERVICAL SPINE, CAPSULAR CONTRACTURES, THINNING BREAST SKIN, POLYARTHRITIS, RAYNAUD'S PHENOMENON, INFLAMMATORY ARTHRITIS, DIZZINESS, LESIONS, HYPERCHOLESTEROLEMIA AND OSTEOARTHRITIS. (ALSO SEE MW1000596 AND 1000597.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST IMPLANT, 175 CC FTR DOW CORNING CORP. HH2154

    Patients

    Seq Age Sex Outcome Treatment
    1 *