BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK 5MM SINGLE USE INSTRUMENT

    MDR report key: 1149546 · Received September 2, 2008

    Report

    Report Number
    2647580-2008-00508
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K944415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SUBMITTED: 09/02/2008.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: TRACKER WAS PRESSED AGAINST ABDOMINAL WALL AND SHAFT BROKE AWAY FROM HANDLE. NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS LAP VENTRAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK 5MM SINGLE USE INSTRUMENT SURGICAL FIXATION DEVICE GDW PONCE - USS P8D0440

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR