BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK EFX CLASSIC

    MDR report key: 22966921 · Received September 4, 2025

    Report

    Report Number
    MW5175626
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 29, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PORTION OF TIP OF WECK FASCIAL CLOSURE DEVICE BROKE OFF INSIDE PATIENT ABDOMEN DURING FASCIAL CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495851 WECK EFX CLASSIC INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF TELEFLEX MEDICAL LLC EFXCT1 ML-000902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown