BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK MAMMARY PROSTHESIS

    MDR report key: 13439 · Received May 23, 1994

    Report

    Report Number
    MW1002154
    Date Received
    May 23, 1994
    Date of Event
    December 27, 1977
    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, 1002153 AND 1002155.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 5283-77I

    Patients

    Seq Age Sex Outcome Treatment
    1 *