BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 23003089 · Received September 9, 2025

    Report

    Report Number
    23003089
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 2, 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

    DURAMESH NEEDLE BROKE FROM MESH WHILE SUTURING IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440670 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE INC. MSI-500 F423OEF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown