BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILUME PROCEDURE

    MDR report key: 22197724 · Received June 12, 2025

    Report

    Report Number
    MW5171451
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    October 15, 2024
    Report Date
    June 4, 2025
    Manufacturer
    LABORIE/UROTRONIC INC
    Product Code
    QXB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD AN OPTILUME PROCEDURE FOR BENIGN PROSTATIC HYPERTROPHY ON (B)(6) 2024. I EXPERIENCED BLEEDING/HEMATURIA INTO (B)(6) 2025. I HAVE HAD FREQUENT BOUTS OF PROSTATITIS REQUIRING ORAL ANTIBIOTICS SINCE THE PROCEDURE. I ALSO HAVE BEEN INCONTINENT WHEN BENDING, COUGHING, STRAINING, BLOWING MY NOSE, SNEEZING, LIFTING SINCE THE FOLEY CATHETER WAS REMOVED ON (B)(6) 2024. MY URINALYSIS IS STILL SHOWING BLOOD AS RECENT AS THIS WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008249 OPTILUME PROCEDURE DRUG COATED PROSTATIC DILATION CATHETER FOR BENIGN PROSTATIC HYPERPLASIA QXB LABORIE/UROTRONIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other BABY ASA DAILY.| CRESTOR 20MG DAILY.| FLOMAX 0.4MG DAILY.| OZEMPIC 2MG WEEKLY.| PROPANTAZOLE 40MG DAILY.| VITAMIN D DAILY.| VITAMIN D.| ZOLOFT 50 MG DAILY.