BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROPASS

    MDR report key: 24477585 · Received March 2, 2026

    Report

    Report Number
    24477585
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 11, 2026
    Report Date
    February 18, 2026
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    KNY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNABLE PULL INNER PART OUT. FAULTY FROM MANUFACTURER. THE ITEM WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540173 UROPASS ACCESSORIES, CATHETER, G-U KNY GYRUS ACMI, LLC 61046BX 09K2400097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other