BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 23427376 · Received October 30, 2025

    Report

    Report Number
    23427376
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 16, 2025
    Manufacturer
    MESH SUTURE INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NEEDLE DISCONNECTED FROM DURAMESH SUTURE WHEN REMOVING FROM PACKAGING. ITEM PIECES SET ASIDE, REPLACEMENT OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702663 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE INC. MSI-500 F423OEF

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male