BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK MAMMARY IMPLANT

    MDR report key: 36750 · Received September 3, 1996

    Report

    Report Number
    2182596-1996-00005
    Event Type
    Injury
    Date Received
    September 3, 1996
    Report Date
    August 19, 1996
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGATIONS OF SCLERODERMA, SJOGREN'S SYNDROME, HAIR LOSS, COGNITIVE DYSFUNCTION, MYALGIAS, ARTHRALGIAS, CHRONIC FATIGUE, OBSTRUCTIVE AIRWAY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK MAMMARY IMPLANT Implant POLYURETHANE-COVERED MAMMARY IMPLANT FTR MEDICAL ENGINEERING CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention