BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARP TIP TROCAR OR BLUNT TROCAR

    MDR report key: 19447930 · Received June 3, 2024

    Report

    Report Number
    3003477176-2024-00388
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 31, 2024
    Manufacturer
    UROMEDICA INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    URETHRAL PERFORATION, THE IMPLANTATION WAS STILL COMPLETED, A FOLEY CATHETER WAS PLACED AND WILL BE LEFT FOR 3-5 DAYS WHILE THE PERFORATION HEALS.

    Description of Event or Problem · 0

    URETHRAL PERFORATION, THE IMPLANTATION WAS STILL COMPLETED, A FOLEY CATHETER WAS PLACED AND WILL BE LEFT FOR 3-5 DAYS WHILE THE PERFORATION HEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940883 SHARP TIP TROCAR OR BLUNT TROCAR TROCAR EZY UROMEDICA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other