BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGY SET

    MDR report key: 19759955 · Received July 17, 2024

    Report

    Report Number
    19759955
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    April 9, 2024
    Report Date
    April 25, 2024
    Manufacturer
    THERMEDX, LLC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RED PORTION OF INFLOW TUBING FOR THE THERMEDX IN UROLOGY HAD A HOLE IN THE MIDDLE OF IT AND WATER WENT EVERYWHERE AS CASE WAS STARTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507556 UROLOGY SET ARTHROSCOPE HRX THERMEDX, LLC LL0006 114437

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male