BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT BLUNT TROCAR, PACKAGED (USA)

    MDR report key: 11995718 · Received June 14, 2021

    Report

    Report Number
    3003477176-2021-00006
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 14, 2021
    Manufacturer
    UROMEDICA, INC.
    Product Code
    EZY
    UDI-DI
    00180668000137
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR. (B)(6) WAS PRESIDING THE CASE WITH A RESIDENT ASSISTING. THE PATIENT'S BLADDER WAS PERFORATED WITH THE BLUNT TROCAR AND FLUID RAN OUT OF THE PAIRED U-SHEATH WHEN THE BLUNT TROCAR WAS REMOVED. THE PHYSICIAN PLACED THE BALLOON, WHICH WAS DELIVERED TO THE BLADDER. THE PHYSICIAN THEN IMPLANTED A BALLOON ON THE CONTRALATERAL SIDE, AFTER WHICH, HE DEFLATED AND REMOVED THE BALLOON THAT HAD BEEN PLACED ON THE SIDE THAT HAD BEEN PERFORATED. THE PATIENT WAS THEN CATHETERIZED WITH PLANS FOR IMPLANTING A SECOND BALLOON ON THE PERFORATED SIDE AFTER THE PERFORATION HAS ADEQUATELY HEALED. (B)(4).

    Description of Event or Problem · 1

    BLADDER PERFORATION DURING A PROACT IMPLANTATION PROCEDURE. PATIENT WAS TREATED WITH A CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886511 PROACT BLUNT TROCAR, PACKAGED (USA) TROCAR EZY UROMEDICA, INC. 750042 UNKNOWN 00180668000137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention