BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSTEM

    MDR report key: 3123774 · Received May 14, 2013

    Report

    Report Number
    1044475-2013-00076
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT# IS AVAILABLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE TIP OF THE EFX NEEDLE BROKE WHILE THE DOCTOR WAS TRYING TO GET IT THROUGH THE PTS ABDOMINAL WALL. THIS WAS DUE TO A LARGE AMOUNT OF DOWNWARD PRESSURE BEING APPLIED TO THE DEVICE WHICH CAUSE THE NEEDLE TO MISS THE SILICON PAD AND STRIKE THE OUTWARD WALL OF THE WINGS. NO REPORTED PT INJURY. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212855 WECK ENDO FASCIAL CLOSURE SYSTEM FASCIAL CLOSURE SYSTEM GCJ TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1