BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLOGY SET

    MDR report key: 24687580 · Received March 25, 2026

    Report

    Report Number
    24687580
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    June 19, 2025
    Report Date
    March 13, 2026
    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

    STAFF REPORTED BROWN BIOBURDEN FOUND INSIDE THE STERILE POUCH. A NEW ONE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749549 UROLOGY SET ARTHROSCOPE HRX THERMEDX, LLC LL0006 115161

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other