BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK MAMMARY PROSTHESIS

    MDR report key: 13493 · Received May 24, 1994

    Report

    Report Number
    MW1002192
    Date Received
    May 24, 1994
    Date of Event
    October 25, 1982
    Report Date
    May 13, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF TUMORS, CAPSULAR CONTRACTURES, FATIGUE, ACHES AND PAINS IN JOINTS, ARTHRITIS, AUTOIMMUNE PROBLEMS, PHYSICAL IMPAIRMENT ON LEFT SIDE, LUNG CANCER, MUSCLE INFLAMMATION, CYSTITIS, INFECTION IN BREAST, TREMORS OR MUSCLE SPASMS, RUPTURED IMPLANTS, RASHES, SKIN ABNORMALITIES, BURNING PAIN IN CHEST, BREAST, ARMS, RIBS AND ABDOMEN, DRY MOUTH AND VAGINA, JOINT SWELLING AND TENDERNESS, ENLARGED LYMPH NODES, MUSCLE ACHES, PAINS AND WEAKNESS, PHOTOSENSITIVITY, SLEEP DISTURBANCE, EASY BRUISING, TROUBLE SWALLOWING, NIGHT SWEATS, NOSE AND MOUTH ULCERS, LOW GRADE FEVERS, AND TINGLING IN LEGS, ARMS AND ELSEWHERE. (SAME RPTR REFERRED TO IN 1002191 AND 1002193.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 1546-81-A

    Patients

    Seq Age Sex Outcome Treatment
    1 * *