BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE MEDIUM UTERINE MANIPULATOR

    MDR report key: 8388043 · Received March 4, 2019

    Report

    Report Number
    MW5084599
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 1, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON INITIAL ATTEMPT TO INFLATE BALLOON ACCORDING TO MANUFACTURER¿S RECOMMENDATIONS, OUR CONMED CORPORATION, VCARE, MEDIUM, VAGINAL-CERVICAL-AHLUWALIA¿S-RETRACTOR-ELEVATOR, BALLOON WAS LEAKING. THE BALLOON WOULD NOT HOLD THE AIR BEING INTRODUCED, SO THE DEVICE HAD TO BE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180417 VCARE MEDIUM UTERINE MANIPULATOR CANNULA MANIPULATOR/INJECTOR, UTERINE LKF CONMED CORPORATION 60-6085-201A 201812171

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR