BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACKER 5MM

    MDR report key: 1960052 · Received January 5, 2011

    Report

    Report Number
    1960052
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 5, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    AFTER FIRING 7 OR 8 TACKS, THE TACKS ONLY CAME OUT PART OF THE WAY FROM THE DEVICE.MANUFACTURER RESPONSE FOR FIXATION DEVICE, TACKER: NO RESPONSE SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACKER 5MM FIXATION DEVICE GDW COVIDIEN OMSTTSD30 P0J0782

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR NONE KNOWN.