BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-CLOSE KIT

    MDR report key: 21908738 · Received April 25, 2025

    Report

    Report Number
    21908738
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 21, 2025
    Manufacturer
    NEW WAVE ENDO
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTED THAT THE DEVICE IS BROKEN/ DEFECTIVE OUT OF PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289027 M-CLOSE KIT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF NEW WAVE ENDO 27-101 L1624

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female