BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTATION INSTRUMENT SET

    MDR report key: 19715413 · Received July 10, 2024

    Report

    Report Number
    3003477176-2024-00021
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 2, 2024
    Manufacturer
    UROMEDICA INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DOCTOR PLANS ON REPLACING THE RIGHT DEVICE ONCE THE PERFORATION HEALS.

    Description of Event or Problem · 0

    URETHRA PERFORATION, PATIENT RIGHT SIDE BALLOON WAS DELIVERED INTO THE URETHRA. A FOLEY CATHETER WAS PLACED. CYSTOSCOPY CONFIRMED RIGHT SIDE BALLOON WAS DELIVERED INTO THE URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354972 IMPLANTATION INSTRUMENT SET TROCAR EZY UROMEDICA INC. 750041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other