BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARP-TIP TROCAR OR BLUNT-TIP TROCAR

    MDR report key: 14310750 · Received May 6, 2022

    Report

    Report Number
    3003477176-2022-00009
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 5, 2022
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    LEFT-SIDE URETHRAL PERFORATION DURING A BILATERAL PROACT REVISION PROCEDURE. THE LEFT-SIDE DEVICE WAS NOT PLACED. THE PATIENT'S RIGHT-SIDE PROACT WAS PLACED SUCCESSFULLY. THE PATIENT WAS CATHETERIZED AND SENT HOME WITH THE CATHETER IN PLACE. THE PHYSICIAN PLANS TO IMPLANT THE PATIENT'S LEFT-SIDE WITH PROACT ONCE THE PERFORATION HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204370 SHARP-TIP TROCAR OR BLUNT-TIP TROCAR TROCAR EZY UROMEDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention