BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 20296971 · Received September 24, 2024

    Report

    Report Number
    3003477176-2024-00025
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    May 5, 2024
    Report Date
    September 24, 2024
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    UDI-DI
    00180668000380
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROACT PAS STUDY SUBJECT #(B)(6).

    Description of Event or Problem · 0

    GROSS HEMATURIA. BEGAN PASSING CLOTS ON (B)(6). STRAIGHT CATH IN ER. HOURS LATER RETURNED TO ER WHERE CBI COMPLETED AND FOLEY CATH PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239135 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC. 800018-14 UM00981 00180668000380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R