BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE

    MDR report key: 755940 · Received August 17, 2006

    Report

    Report Number
    MW1040083
    Event Type
    Malfunction
    Date Received
    August 17, 2006
    Date of Event
    June 29, 2006
    Report Date
    July 25, 2006
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROTACK AUTOSUTURE INSTRUMENT FAILED TO RELEASE TACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE 5MM PROTACK GDW UNITED STATES SURGICAL PTACK30 P6B427

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR