BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EFX

    MDR report key: 4797784 · Received May 20, 2015

    Report

    Report Number
    4797784
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Date of Event
    January 1, 2015
    Report Date
    May 20, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE WECK INSTRUMENT, WHEN IN LOCKED POSITION WAS SO UNSTABLE AND FLOPPY IT COULD NOT BE USED. A NEW DEVICE WAS OPENED AND NO ISSUES WERE NOTED. MD NOTICED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329324 WECK EFX INSTRUMENT, LIGATURE PASSING GCJ TELEFLEX MEDICAL EFX001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR