BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMESH

    MDR report key: 20757163 · Received November 22, 2024

    Report

    Report Number
    20757163
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 15, 2024
    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

    DURAMESH SUTURE PACKAGE WAS OPENED TO SCRUB TECH. BLACK FLECKS WERE NOTED ON THE MESH. MESH WAS REMOVED FROM FIELD. NO CONTACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605022 DURAMESH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW MESH SUTURE INC. MSI-301 D202AQV

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female