BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 20937967 · Received December 16, 2024

    Report

    Report Number
    20937967
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 13, 2024
    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

    MD WAS TRYING THE MESH AND THE NEEDLE DETACHED FROM THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391583 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE INC. MSI-501 E520IXY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown