BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGY SET

    MDR report key: 22166403 · Received June 9, 2025

    Report

    Report Number
    22166403
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    January 27, 2025
    Report Date
    May 30, 2025
    Manufacturer
    THERMEDX, LLC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE CARTRIDGE STARTED TO LEAK. ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. FORMAL COMPLAINT FILED BY VENDOR (PI# [REDACTED]).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354944 UROLOGY SET ARTHROSCOPE HRX THERMEDX, LLC LL0006 23F46N

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male