BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK MAMMARY PROSTHESIS

    MDR report key: 13486 · Received May 24, 1994

    Report

    Report Number
    MW1002185
    Date Received
    May 24, 1994
    Date of Event
    October 13, 1989
    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 ACHES AND PAINS, BREAST HARDNESS, PAINFUL BREASTS, ITCHING, REDNESS AND SWELLING OF SKIN, SWOLLEN LYMPH NODES, SWELLING OF JOINTS AND HANDS, FATIGUE, UNUSUAL HAIR LOSS, RASHES, SHORTNESS OF BREATH, INFECTIONS, AND LOW BLOOD PRESSURE. (SAME RPTR REFERRED TO IN 1002184, 1002186 - 1002188.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 44023-88K, 44253-88K

    Patients

    Seq Age Sex Outcome Treatment
    1 * *