BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 22318039 · Received June 24, 2025

    Report

    Report Number
    22318039
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MESH SUTURE INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SURGEON WENT TO USE DURAMESH (MSI-501) AND THE NEEDLE BROKE OFF FIRST THING. NO PATIENT HARM OCCURRED, ANOTHER BOX WAS OPENED, I ALREADY FOLLOWED UP WITH THE COMPANY ABOUT THE DEFECTIVE PRODUCT AND GAVE THEM APPROPRIATE LOT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579711 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE INC. MSI-501 E5201XW

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female