BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN

    MDR report key: 14579355 · Received June 2, 2022

    Report

    Report Number
    3003477176-2022-00012
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 2, 2022
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UROMEDICA REPRESENTATIVE PRESENT AT THE CASE REPORTED THAT THE PHYSICIAN FILLED THE BALLOON ABOVE THE RECOMMENDED FILL VOLUME OF 1.5ML. THE UROMEDICA REPRESENTATIVE SUSPECTED THAT THE CATHETER MAY HAVE CAUGHT ON THE OVERFILLED BALLOON OF THE IMPLANTED PROACT DEVICE FROM THE INSIDE OF THE PATIENT'S URETHRA DURING DEPLOYMENT OF THE CATHETER. THIS CATCH ON THE BALLOON WAS LIKELY THE "BOTTOMED OUT" FEELING REPORTED BY THE PHYSICIAN WHICH IS SUSPECTED TO HAVE CAUSED THE URETHRAL PERFORATION. UROMEDICA COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    LEFT-SIDE URETHRAL PERFORATION DURING A UNILATERAL PROACT REVISION PROCEDURE. POST OPERATIVE IMAGES CONFIRMED THAT THE DEVICE WAS INITIALLY PLACED WITHOUT ISSUE. THE PHYSICIAN THEN CATHETERIZED THE PATIENT AND FELT THE CATHETER "BOTTOM OUT". ADDITIONAL REVIEW OF DEVICE PLACEMENT CONFIRMED THAT THE URETHRAL WALL HAD BEEN PERFORATED, AND THE BALLOON HAD MIGRATED THROUGH THE PATIENT'S URETHRA AND INTO THE BLADDER. THE PROACT DEVICE WAS REMOVED AND THE PATIENT WAS SENT HOME WITH THE CATHETER IN PLACE. THE PHYSICIAN PLANS TO IMPLANT THE PATIENT'S LEFT-SIDE WITH PROACT ONCE THE PERFORATION HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216532 PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention