BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 23407786 · Received October 28, 2025

    Report

    Report Number
    3003477176-2025-00020
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD BEEN PREVIOUSLY IMPLANTED WITH PROACT BY A DIFFERENT SURGEON (CIRCA 2022). RIGHT-SIDE PROACT DEVICE WAS FOUND DEFLATED AND NEEDED REPLACEMENT. FLUOROSCOPIC IMAGING SUGGESTS THE PATIENT MAY HAVE BEEN SUBJECT TO PRIOR RADIOTHERAPY BASED THE PRESENCE OF A FIDUCIAL MARKER. THE IN SITU MARKER MAY HAVE CAUSED THE DEFLATION OF THE PROACT DEVICE. SURGEON AND UROMEDICA REPRESENTATIVE NOTICED SOME BLEEDING DURING THE REVISION CASE, BUT NOTHING EXCESSIVE NOR OUT OF THE ORDINARY. CASE WAS OTHERWISE NORMAL AND A SUCCESS. THE PATIENT WOKE UP IN THE RECOVERY ROOM AFTER THE REVISION CASE IN EXTREME PAIN. PATIENT LOST 500-700 CC OF BLOOD. BLOOD LOSS WAS SLOWED WITH COAGULATION AGENT, BUT COULD NOT BE STOPPED COMPLETELY. SURGEON REPORTED TO UROMEDICA REPRESENTATIVE THAT THE PATIENT MAY LIKELY HEAD TO THE ER FOR EMBOLIZATION/FURTHER INTERVENTION. ON (B)(6) 2025, POST-OP. DIAGNOSTICS SHOWED NOTHING CONCERNING. NO FURTHER INTERVENTION WAS PERFORMED AND THE PATIENT IS ALMOST COMPLETELY DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588799 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening