BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE

    MDR report key: 558860 · Received November 15, 2004

    Report

    Report Number
    MW1033773
    Event Type
    Malfunction
    Date Received
    November 15, 2004
    Date of Event
    October 21, 2004
    Report Date
    November 11, 2004
    Manufacturer
    UNITED STATES SURGICAL/TYCO HEALTHCARE GROUP
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROTACK FIRED THE FIRST TIME. ON THE SECOND ATTEMPT A CRACK WAS HEARD AND IT FAILED TO FIRE. A RATTLING WAS HEARD IN THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE PROTACK 5MM GDO UNITED STATES SURGICAL/TYCO HEALTHCARE GROUP PTACK#30 P4J304

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other