BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EFX

    MDR report key: 3378262 · Received September 6, 2013

    Report

    Report Number
    3378262
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Date of Event
    August 12, 2013
    Report Date
    September 6, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING USE THE DEVICE JAMMED (WINGS WOULD NOT OPEN PROPERLY). A NEW DEVICE WAS OPENED AND USED SUCCESSFULLY ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444012 WECK EFX LAPAROSCOPIC ENDO FASCIAL CLOSURE SYSTEM GCJ TELEFLEX MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR