BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 25200096 · Received May 18, 2026

    Report

    Report Number
    25200096
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 11, 2026
    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

    MESH SUTURE NEEDLE DETACHED WHILE SUTURING. NEW SUTURE OBTAINED AND UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247450 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE INC. MSI-300 G225NNU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other