BEUDAMED
    FDA Adverse Event Summary report: N

    HIGH PROFILE, 400 CC

    MDR report key: 10628 · Received December 21, 1993

    Report

    Report Number
    MW1000197
    Date Received
    December 21, 1993
    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

    ON 5/15/91, RPTR HAD REMOVAL OF SILASTIC IMPLANTS WITH REPLACEMENT USING THIS CO'S IMPLANTS. PROBLEMS SUSPECTED OR NOTED: CAPSULAR CONTRACTURES, POSSIBLE SILICONE LEAKAGE, ARTHRITIS SYMPTOMS IN HANDS, FEET, ELBOWS, SHOULDERS AND BACK, EXTREME FATIGUE, LEFT ARM SHAKING ON EXERTION, HAND FINGER AND FEET SWELLING, BREAST TENDERNESS, GENERAL ACHING WITH STIFFNESS, VISIBLE IMPLANT WRINKLES, IMPLANT MIGRATION, EDEMA OF HANDS AND FEET, LOSS OF STRENGTH WITH PAIN IN BACK, LEFT ARM, HAND AND LEFT SHOULDER, AND NUMBNESS IN FINGERS OF LEFT HAND. (SAME RPTR REFERRED TO IN 1000195 AND 1000196.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH PROFILE, 400 CC FTR MCGHAN MEDICAL CORP. STYLE 120 EB9154, EG3966

    Patients

    Seq Age Sex Outcome Treatment
    1 *