BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN

    MDR report key: 14254821 · Received April 29, 2022

    Report

    Report Number
    3003477176-2022-00008
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 25, 2022
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT#: (B)(4).

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - IMPACT, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES UPDATED AFTER COMPLETION OF DEVICE ANALYSIS. UROMEDICA COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    RIGHT-SIDE URETHRAL EROSION IN A PROACT PATIENT. THE PATIENT WAS UNILATERIALLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976284 PROACT ADJUSTIBLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention