BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE UTERINE MANIPULATOR

    MDR report key: 6705830 · Received July 10, 2017

    Report

    Report Number
    MW5070922
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 10, 2017
    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

    THE BALLOONS ON BOTH CONMED CORPORATION VCARE MEDIUM UTERINE MANIPULATORS WOULD NOT INFLATE WHEN TRIALED PRIOR TO USE. THE DEVICES WERE NOTED TO BE FROM TWO DIFFERENT LOT #S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480412 VCARE UTERINE MANIPULATOR VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 60-6085-201A 201703201
    480413 VCARE UTERINE MANIPULATOR VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 60-6085-201A 201704101

    Patients

    Seq Age Sex Outcome Treatment
    1