BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILUME BPH CATHETER SYSTEM

    MDR report key: 25284259 · Received May 26, 2026

    Report

    Report Number
    MW5188631
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 21, 2026
    Manufacturer
    UROTRONIC INC / LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    QXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAD THE OPTILUME BPH SURGERY FOR TYPICAL BPH (BENIGN PROSTATIC HYPERPLASIA) SYMPTOMS, WEAKENING FLOW, URGENCY AND MILD TO MODERATE BLADDER DAMAGE AS SHOWN BY CYSTOSCOPE. SINCE THE PROCEDURE I HAVE BEEN DEALING WITH STRESS INCONTINENCE. NO WHERE IN ANY INFORMED CONSENT THAT I READ FROM THE MANUFACTURER, LABORIE, OR THE SURGEON WAS THIS EVER MENTIONED AS A POSSIBLE SIDE EFFECT. I SPECIFICALLY CHOSE THIS SURGERY AS IT IS STATED AS POSSIBLE SIDE EFFECT OF MOST OTHER BPH SURGICAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421666 OPTILUME BPH CATHETER SYSTEM DRUG COATED PROSTATIC DILATION CATHETER FOR BENIGN PROSTATIC HYPERPLASIA QXB UROTRONIC INC / LABORIE MEDICAL TECHNOLOGIES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1