BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 21967828 · Received May 6, 2025

    Report

    Report Number
    21967828
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 29, 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 WAS OPENED TO STERILE FIELD FROM PACKAGE. MD BEGAN SEWING DURAMESH IN PATIENT FOR PARASTOMAL HERNIA REPAIR AND NEEDLE CAME DETACHED FROM MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69028 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE, INC. MSI-501

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male