BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 14347883 · Received May 10, 2022

    Report

    Report Number
    3003477176-2022-00011
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 10, 2022
    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

    NOTE THAT THE PROACT IFU INSTRUCTS THE PHYSICIAN TO INJECT EACH PROACT DEVICE WITH UP TO 1.5ML OF FLUID AT THE TIME OF THE IMPLANT PROCEDURE. IN THIS CASE, THE IMPLANTING PHYSICIAN HAD FILLED EACH PROACT DEVICE WITH 2ML OF FLUID. IT IS UNCLEAR WHETHER THIS OVERFILLING CAUSED THE PATIENT'S ACUTE URINARY RETENTION. UROMEDICA COMPLAINT (B)(4).

    Description of Event or Problem · 0

    POSTOPERATIVE ACUTE URINARY RETENTION IN A PROACT PATIENT. THE PATIENT EXPERIENCED RETENTION SYMPTOMS IN THE MORNING FOLLOWING HIS PROACT IMPLANATION PROCEDURE. THE IMPLANTING PHYSICIAN REMOVED 0.5ML FROM EACH PROACT BALLOON AND THE PATIENT WAS ABLE TO VOID WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601563 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC 800018-14 00180668000380

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention