BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 20343594 · Received October 1, 2024

    Report

    Report Number
    20343594
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    June 22, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MESH SUTURE INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN CLOSING THE FIRST FASCIAL LAYER WITH NEW DURAMESH SUTURE, THE NEEDLE ATTACHED TO THE SUTURE CAME OFF. DRS. WERE UNSURE IF THIS WAS A FAULTY PRODUCT, OR USER ERROR. PACKAGING RETURNED TO EMI BIN IN BIOHAZARD BAG FOR FAULTY SUTURE. TWO OTHER OF THESE DURAMESH WERE USED IN THE PATIENT WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916094 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE INC. DURAMESH 1 HR48

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female