BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILUME BALLOON

    MDR report key: 25095226 · Received May 6, 2026

    Report

    Report Number
    MW5187773
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    January 10, 2026
    Report Date
    April 30, 2026
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES/UROTRONIC, INC.
    Product Code
    QRH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    003
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER THE OPTILUME PROCEDURE, HAVE URINARY INCONTINENCE. HAVE LEAKAGE ESPECIALLY WHEN ACTIVE. DID NOT HAVE INCONTINENCE BEFORE PROCEDURE. MUST USE LEAKAGE PADS OR URINARY DRAINAGE CUP WITH COLLECTION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494515 OPTILUME BALLOON CATHETER, BALLOON, URETHRAL, DRUG-COATED QRH LABORIE MEDICAL TECHNOLOGIES/UROTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other B12| B6| BEET ROOT| CO-Q 10| D3| DEVIL'S CLAW| ELIQUIS| FISH OIL| FOLIC ACID| JOINT SUPPLEMENT| K2 | MAGNESIUM COMPLEX| METOPROLOL| MULTIVITAMIN| ROSUVASTATIN| VITAMIN C