BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 11896882 · Received May 27, 2021

    Report

    Report Number
    3003477176-2021-00005
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 27, 2021
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    URINARY RETENTION WAS PRESENT IMMEDIATELY AFTER THE DEVICE IMPLANT PROCEDURE. WITH THE INTERVENTION OF CATHETERIZATION, THE PATIENT'S URINARY RETENTION WAS RESOLVED WITHIN 2 DAYS. (B)(4).

    Description of Event or Problem · 1

    URINARY RETENTION IN A PROACT PATIENT. PATIENT WAS TREATED WITH A FOLEY CATHETER AND URINARY RETENTION WAS RESOLVED WITH NO RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790265 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention