BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK 5MM INSTRUMENT

    MDR report key: 1082371 · Received July 25, 2008

    Report

    Report Number
    2647580-2008-00428
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    March 17, 2008
    Report Date
    July 22, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE ENTIRE SPRING AND TACKS FELL OUT OF THE SHAFT. THE ITEMS WERE REMOVED FROM THE PATIENT'S ABDOMINAL CAVITY. NO INJURY TO PATIENT OR SEVERE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK 5MM INSTRUMENT SURGICAL FIXATION DEVICE GDW PONCE - USS P7H0478

    Patients

    Seq Age Sex Outcome Treatment
    1