BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK* 5MM INSTRUMENT

    MDR report key: 4121525 · Received September 26, 2014

    Report

    Report Number
    2647580-2014-00814
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    December 10, 2012
    Report Date
    December 13, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K090470
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SHAFT WAS BROKEN AFTER 2 FIRES. MALE PATIENT INVOLVED W/O INJURY; PROCEDURE: HERNIA REPAIR; MEDICAL INTERVENTION REQUIRED; SURGERY TIME NOT EXTENDED; PRODUCT NOT TESTED PRIOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601497 PROTACK* 5MM INSTRUMENT PROTACK GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC 174006 P2D0473X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other