BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TROCAR

    MDR report key: 19715027 · Received July 10, 2024

    Report

    Report Number
    3003477176-2024-00022
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 9, 2024
    Manufacturer
    UROMEDICA INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT MAY BE SCHEDULED FOR REIMPLANT IN 5-6WEEKS. PATIENT'S LEFT SIDE IMPLANTED SUCCESSFULLY.

    Description of Event or Problem · 0

    BLADDER PERFORATION WITH THE BLUNT TROCAR ON PATIENT'S RIGHT SIDE. A FOLEY CATHETER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040805 BLUNT TROCAR TROCAR EZY UROMEDICA INC. 750042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other