BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK BREAST IMPLANT

    MDR report key: 11632 · Received February 17, 1994

    Report

    Report Number
    MW1000811
    Date Received
    February 17, 1994
    Date of Event
    April 25, 1991
    Report Date
    February 9, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANTS RUPTURED AND HAD TO BE REMOVED. (SAME PT REFERRED TO IN 1000812.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK BREAST IMPLANT FTR MEDICAL ENGINEERING CORP. 0476-78-G

    Patients

    Seq Age Sex Outcome Treatment
    1 *