BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBATACK

    MDR report key: 2082639 · Received May 2, 2011

    Report

    Report Number
    2082639
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 2, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SHAFT OF THE ABSORBATACK FIXATION DEVICE BENT AND SEPARATED AFTER THE PHYSICIAN APPLIED A COUPLE OF TACKS. NO HARM TO THE PATIENT. PROCEDURE CONTINUED USING NEW ABSORBATACK FIXATION DEVICE (SAME KIND). THE REPRESENTATIVE WILL BE CONTACTED TO PICK UP THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORBATACK FIXATION DEVICE GDW COVIDIEN ABSTACK30 N1B0939UX

    Patients

    Seq Age Sex Outcome Treatment
    1 *