BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROACT¿ ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 23086947 · Received September 18, 2025

    Report

    Report Number
    MW5176262
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Report Date
    July 7, 2025
    Manufacturer
    UROMEDICAL INC.
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO REMOVE A PROACT DEVICE AND REPLACE IT WITH AN ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO UNSPECIFIED REASONS. NO PATIENT COMPLICATIONS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287206 PROACT¿ ADJUSTABLE CONTINENCE THERAPY FOR MEN DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC EZY UROMEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown