BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 19823161 · Received July 24, 2024

    Report

    Report Number
    3003477176-2024-00023
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 24, 2024
    Manufacturer
    UROMEDICA INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESOLVED, NO RESIDUAL EFFECT. PROPOSED TERM FOR ANNEX-C: ADVERSE EVENT WITHOUT CONCLUSIVE FINDING.

    Description of Event or Problem · 0

    PAIN AND DISCOMFORT AFTER PROACT BALLOON ADJUSTMENT. PATIENT RETURNED TO CLINIC 24 HOURS AFTER THE 6 WEEK PROACT BALLOON ADJUSTMENT AND REPORTED PERINEAL PAIN AND DIFFICULTY WHILE SITTING.THE PATIENT INITIALLY WAS ABLE TO URINATE WELL AND AFTER A FEW HOURS, THE URINE STREAM WAS REDUCED TO A TRICKLE. 0.5ML WAS REMOVED FROM LEFT AND RIGHT PROACT BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370974 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN UROLOGICAL IMPLANT EZY UROMEDICA INC. 800018-14 UM00985

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R