BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 23872015 · Received December 22, 2025

    Report

    Report Number
    3003477176-2025-00022
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 22, 2025
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    UDI-DI
    00180668000380
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT BI-LATERAL IMPLANTATION OF PROACT. PATIENT HAD PREVIOUS BLADDER NECK CONTRACTURE AND RADIATION THERAPY. PATIENT WAS IN RETENTION AFTER A CYSTOSCOPY ONE WEEK PRIOR TO THE PROACT PROCEDURE. EACH DEVICE HAD 1CC FLUID. URETHRA WAS CLOSED SHUT DURING POST-OP CYSTOSCOPY. ONE WEEK LATER, PATIENT WAS IN RETENTION. DEVICES WERE FULLY DEFLATED AND STILL IN RETENTION. THEN, PATIENT HAD GROSS HEMATURIA, SUSPICIOUS FOR AN ERODED DEVICE. PATIENT CAME BACK TO OR FOR CYSTOSCOPY AND TO ADDRESS RECURRING BLADDER NECK CONTRACTURE. PATIENT LEFT DEVICE WAS ERODED AND REMOVED. PATIENT RIGHT DEVICE WAS REINFLATED TO 0.5CC,AND THEN CYSTOSCOPY SHOWED EROSION, SO THAT WAS REMOVED TOO. PATIENT SENT HOME WITH A FOLEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403449 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC. 800018-14 00180668000380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention