BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROACT : ADJUSTABLE CONTINENCE THERAPY ARTIFICIAL BALLOON URINARY SPHIN

    MDR report key: 21038330 · Received December 27, 2024

    Report

    Report Number
    MW5164058
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    July 10, 2024
    Report Date
    December 18, 2024
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE PROACT IMPLANT. BALLOON WAS TESTED (INFLATED WITH SALINE) ON FIELD BY SURGEON AFTER REMOVAL AND FOUND TO HAVE HOLE. NEW IMPLANT TESTED FOR EFFECTIVENESS AND PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134080 PROACT : ADJUSTABLE CONTINENCE THERAPY ARTIFICIAL BALLOON URINARY SPHIN DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC EZY UROMEDICA, INC. 80001814

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male