BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK OPTIMAM MAMMARY PROSTHESIS

    MDR report key: 13440 · Received May 23, 1994

    Report

    Report Number
    MW1002155
    Date Received
    May 23, 1994
    Date of Event
    December 4, 1990
    Report Date
    May 12, 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 CHEST PAIN, WEAKNESS IN BOTH ARMS, THORACIC OUTLET SYNDROME, FIBROMYALGIA, FATIGUE, SLEEP DISORDERS, DEPRESSION, AND RAYNAUD'S SYNDROME. (SAME RPTR REFERRED IN 1002152 - 1002154.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK OPTIMAM MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 10240183, 10240179

    Patients

    Seq Age Sex Outcome Treatment
    1 * *