BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH 2

    MDR report key: 23366252 · Received October 23, 2025

    Report

    Report Number
    23366252
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 22, 2025
    Report Date
    September 29, 2025
    Manufacturer
    MESH SUTURE, INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURAMESH SUTURE OPENED TO STERILE FIELD. WHEN SURGICAL RESIDENT ATTEMPTED TO CLOSE WITH SUTURE, NEEDLE POPPED OFF OF THE DURAMESH ITSELF AND WAS UNABLE TO BE USED FOR CLOSURE. THIS HAPPENED AGAIN WITH A REPLACEMENT BOX OF DURAMESH FROM THE SAME LOT THAT WAS USED. THE THIRD BOX THAT WAS OPENED DID NOT HAVE THIS ISSUE AND WAS ABLE TO BE USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730574 DURAMESH 2 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE, INC. E613UVU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male