BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK

    MDR report key: 3994137 · Received July 25, 2014

    Report

    Report Number
    3994137
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    April 21, 2014
    Report Date
    July 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING A LAPAROSCOPIC REPAIR OF INCARCERATED VENTRAL INCISIONAL HERNIA WITH MESH IMPLANTATION. THE SURGEON COULD NOT GET THE PROTACK AUTO SUTURE DEVICE (5MM, REF # 174006, LOT # P3G0117X) TO FIRE. THE DEVICE WAS REPLACED AND FUNCTIONED WITHOUT INCIDENT. NO HARM TO THE PATIENT.======================MANUFACTURER RESPONSE FOR AUTO SUTURE, PROTACK AUTO SUTURE FIXATION DEVICE (PER SITE REPORTER).======================NO KNOWN RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436156 PROTACK STAPLE, IMPLANTABLE GDW COVIDIEN * P3G0117X

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR