BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN

    MDR report key: 16307208 · Received February 6, 2023

    Report

    Report Number
    3003477176-2023-00006
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 30, 2023
    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

    REVISED SECTION B5 WITH DETAIL OF EXPLANTED SIDE REPORTED. NO IMPACT ON THE OUTCOME OF THE INVESTIGATION OR THE ADVERSE EVENT CODING. UROMEDICA COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    THE PATIENT PRESENTED AT THE ER WITH THE BALLOON EROSION AT A HOSPITAL IN (B)(6) . THE DEVICE WAS EXPLANTED BY (B)(6) AT AN UNKNOWN FACILITY. IN (B)(6) OPINION, THE PREVIOUSLY PLACED 24F CATHETER FOR AN UNRELATED MEDICAL EVENT MAY HAVE CONTRIBUTED TO THE DEVICE EROSION. UROMEDICA COMPLAINT- (B)(4).

    Description of Event or Problem · 0

    UNILATERAL (LEFT-SIDE) BALLOON EROSION IN A PROACT PATIENT, NECESSITATING EXPLANT.

    Description of Event or Problem · 0

    UNILATERAL BALLOON EROSION IN A PROACT PATIENT, NECESSITATING EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114928 PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention