BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSTEM

    MDR report key: 4759422 · Received May 7, 2015

    Report

    Report Number
    1044475-2015-00160
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 13, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE WINGS OF EFX COULD NOT HOLD THE WEIGHT OF THE ABDOMINAL WALL; THE EFX BROKE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301175 WECK ENDO FASCIAL CLOSURE SYSTEM SUTURE GCJ TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1