BEUDAMED
    FDA Adverse Event Summary report: N

    HIGH PROFILE MAMMARY IMPLANT, 440 CC

    MDR report key: 17498 · Received November 2, 1994

    Report

    Report Number
    MW1003954
    Date Received
    November 2, 1994
    Report Date
    November 2, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FLU AND ARTHRITIS SYMPTOMS, SEVERE HYPERTENSION, JOINT SWELLING, PAIN AND STIFFNESS, MUSCLE FATIGUE, BREAST TENDERNESS, FATIGUE, SWOLLEN GLANDS, COLDNESS/PAIN OF EXTREMITIES, FIRST IMPLANTS TOO SMALL, NOW IMPLANTS TOO HEAVY, VISIBLE IMPLANT WRINKLES, COLD ALL OF TIME, LONG HEALING PERIODS, ACHES AND PAINS, SHORTNESS OF BREATH, EMOTIONAL PROBLEMS BECAUSE OF APPEARANCE, MEMORY PROBLEMS, ARTHRITIC COMPLAINTS IN SHOULDERS AND ANKLES, RAYNAUD'S FEVER, CHILLS, PARESTHESIAS, HEADACHES. ALSO SEE 1003950, 1003951, 1003952, 1003953.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH PROFILE MAMMARY IMPLANT, 440 CC Implant FTR MCGHAN MEDICAL CORP. STYLE 120

    Patients

    Seq Age Sex Outcome Treatment
    1 *