BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILUME BPH CATHETER SYSTEM

    MDR report key: 21072099 · Received January 3, 2025

    Report

    Report Number
    3015228875-2024-00005
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    November 11, 2024
    Report Date
    December 11, 2024
    Manufacturer
    UROTRONIC INC.
    Product Code
    QXB
    UDI-DI
    00853095008129
    PMA / PMN Number
    P220029
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 11/11/2024 UROTRONIC WAS NOTIFIED OF A PATIENT WHO WAS PRESENTED IN A HOSPITAL WITH URINARY RETENTION AFTER AN OPTILUME BPH PROCEDURE PERFORMED (B)(6) 2024. THE SYMPTOMS WERE INABILITY TO URINATE AND BLOOD IN THE URINE. THE PATIENT WAS ADMITTED AND UNDERWENT A SUCCESSFUL CLOT EVACUATION AND FULGURATION PROCEDURE AND WAS DISCHARGED ON THE SAME DAY. PATIENT RETURNED TO THE OFFICE ON (B)(6) 2024 FOR CATHETER REMOVAL. THE URINE IN HIS BAG WAS CLEAR, SO THE CATHETER WAS REMOVED, AND THE PATIENT WAS ABLE TO VOID INDEPENDENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600419 OPTILUME BPH CATHETER SYSTEM BPH CATHETER SYSTEM QXB UROTRONIC INC. 1113-30035 30462 00853095008129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O| H