BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK

    MDR report key: 1033862 · Received April 15, 2008

    Report

    Report Number
    1033862
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TACK WOULD NOT RELEASE FROM TACKER WHEN FIRED. IT STAYED "STUCK" IN THE TIP OF THE TACKER HANDPIECE. TOOK TACKER OUT, TRIED TO REFIRE IT. IT DID NOT FUNCTION, OPENED A NEW TACKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK CLOSURE DEVICE GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * P7L0973

    Patients

    Seq Age Sex Outcome Treatment
    1 *