BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSTEM

    MDR report key: 2961230 · Received January 28, 2013

    Report

    Report Number
    1044475-2013-00018
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RETURNED TO MANUFACTURER AT TIME OF THIS REPORT. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE DOCTOR SAID THE NEEDLE BROKE OFF AT THE TIP OF THE NEEDLE WHERE THE SUTURE IS LOADED ON TO THE NEEDLE. THE NEEDLE WAS RETRIEVED FROM THE ABDOMINAL WALL AT THE PORT SITE. NO REPORTED PATIENT INJURY. CURRENT PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38169 WECK ENDO FASCIAL CLOSURE SYSTEM FASCIAL CLOSURE SYSTEM GCJ TELEFLEX EFX03801

    Patients

    Seq Age Sex Outcome Treatment
    1