BEUDAMED
    FDA Adverse Event Summary report: N

    MODERATE PROFILE MAMMARY IMPLANT

    MDR report key: 10663 · Received December 28, 1993

    Report

    Report Number
    MW1000232
    Date Received
    December 28, 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 8/15/91, RPTR HAD A THIRD IMPLANT IMPLANTED IN THE RIGHT BREAST FOR STATUS POST MASTECTOMIES FOR CARCINOMA AND FIBROCYSTIC DISEASE. SHE HAD RECONSTRUCTION OF THE RIGHT BREAST WITH TRAM FLAP AND REPAIR OF EXTENSIVE DONOR DEFECT OF ABDOMINAL WALL AND THIS CO'S MAMMARY IMPLANT PLACED IN ADDITION TO TRAM. RIGHT BREAST SHOWS SEVERE CAPSULAR CONTRACTURE WITH LOSS OF PROJECTION FOLLOWING SKIN SLOUGHS. RPTR EXPERIENCED RHEUMATOD ARTHRITIS, CAPSULAR CONTRACTURES, CARCINOMA, ARTHRITIS WITH SYMPTOMS, JOINT SWELLING, PAIN, STIFFNESS, MUSCLE FATIGUE, SWELLING OF HANDS AND FINGERS, FATIGUE, BREAST TENDERNESS, GENERAL ACHING AND STIFFNESS, SWOLLEN GLANDS, TINGLING OF EXTREMITIES, INCORRECT SIZES OF IMPLANTS WITH ASYMMETRY, VISIBLE WRINKLES, HARDNESS OF BREASTS, IMPLANT NOISES, NUMEROUS OPERATIONS, FOREIGN GIANT CELL REACTION, SCARING, BACK AND KNEE STIFFNESS, MORNING STIFFNESS AND SALINE LEAKAGE. (SAME RPTR REFERRED TO IN 1000230, 1000231, AND 1000233.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODERATE PROFILE MAMMARY IMPLANT FTR MCGHAN MEDICAL CORP. STYLE 110

    Patients

    Seq Age Sex Outcome Treatment
    1 *