BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK BREAST IMPLANT, 255 SIZE 11

    MDR report key: 11225 · Received February 2, 1994

    Report

    Report Number
    MW1000596
    Date Received
    February 2, 1994
    Report Date
    January 26, 1994
    Manufacturer
    MEDICAL ENGINEERING 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 AUGMENTATION MAMMOPLASTY FOR FIBROCYSTIC DISEASE USING ANOTHER CO'S IMPLANT. ON 6/25/82, THE OLD IMPLANTS WERE REPLACED WITH THIS CO'S IMPLANTS. PT HAD 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 HANDS SWELL, GLANDS UNDER ARMS SWELL, HAIR LOSS, COLDNESS AND PAIN OF EXTREMITIES, SECOND IMPLANTS DON'T FEEL RIGHT, HIP REPLACEMENT, GASTRITIS, DEGENERATION OF CERVICAL SPINE, CAPSULAR CONTRACTURES, THINNING BREAST SKIN, POLYARTHRITIS, RAYNAUD'S PHENOMENON, INFLAMMATORY ARTHRITIS, DIZZINESS, LESIONS, HYPERCHOLESTEROLEMIA, OSTEOARTHRITIS. (ALSO SEE MW1000595 AND 1000597.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK BREAST IMPLANT, 255 SIZE 11 FTR MEDICAL ENGINEERING CORP. 0482-80-L, 6766-82-E

    Patients

    Seq Age Sex Outcome Treatment
    1 *