BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 23778398 · Received December 11, 2025

    Report

    Report Number
    3003477176-2025-00021
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 9, 2025
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    UDI-DI
    00180668000304
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS EVENT OCCURRED IN FRANCE AND WAS REPORTED IN FRENCH. THE ENGLISH TRANSLATION OF THE REPORT STATES: A 49-YEAR-OLD PATIENT IS BEING TREATED FOR MULTIPLE SCLEROSIS COMPLICATED BY ATYPICAL BLADDER AND SPHINCTER DYSFUNCTION, ASSOCIATED WITH FLACCID PARAPLEGIA AND SPHINCTER INSUFFICIENCY. DUE TO SEVERE URINARY INCONTINENCE, TWO PROACT BALLOONS WERE IMPLANTED IN THE FIRST QUARTER OF 2025. BEFORE THE PROCEDURE, THE PATIENT PRESENTED WITH SIGNIFICANT URINARY LEAKAGE, WITH A 24 HOUR PAD TEST SHOWING 1.5 LITERS. DESPITE SEVEN INFLATION SESSIONS, THE LEAKAGE PERSISTS, WITH CONSISTENTLY HIGH VOLUMES, EVEN WITH VOLUNTARY FLUID RESTRICTION. THE PATIENT ALSO REPORTS NOCTURNAL LEAKAGE. ENDOSCOPIC EXAMINATION PERFORMED USING AN ENDOSCOPE SHOWS A HEALTHY-APPEARING ANTERIOR URETHRA. AT THE LEVEL OF THE MEMBRANOUS URETHRA, EROSION OF THE RIGHT BALLOON IS OBSERVED, WHICH APPEARS DEFLATED. THE BULGE OF THE LEFT BALLOON IS BARELY VISIBLE. CLINICALLY, INDURATION WITH INFILTRATION IS NOTED AT THE SITE OF THE RIGHT BALLOON INSERTION. IT IS NECESSARY TO REMOVE THE RIGHT BALLOON DUE TO THE OBSERVED EROSION. THIS PROCEDURE TOOK PLACE IN THE THIRD QUARTER OF 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555003 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC. 800018-01 UM01103 00180668000304

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention