BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK MAMMARY PROSTHESIS

    MDR report key: 13467 · Received May 23, 1994

    Report

    Report Number
    MW1002178
    Date Received
    May 23, 1994
    Date of Event
    October 13, 1978
    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 IMPLANT RUPTURE, CONNECTIVE TISSUE DISEASE, HYSTERECTOMY, SULFITE INTOLERANCE, IMMUNE DEFICIENCY, CHRONIC HERPES (SHINGLES), CHRONIC FATIGUE, AND LEFT AND RIGHT CARPAL TUNNEL SYNDROME. (SAME RPTR REFERRED TO IN 1002177.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 9284-78-F

    Patients

    Seq Age Sex Outcome Treatment
    1 *