BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE MEDIUM UTERINE MANIPULATOR

    MDR report key: 8712052 · Received June 18, 2019

    Report

    Report Number
    MW5087435
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 14, 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

    SURGEON TESTING CONMED CORPORATION, VCARE MEDIUM, PER PROCEDURE, PRIOR TO USE, AT WHICH TIME THE BALLOON WAS OBSERVED TO HAVE A LEAK. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499861 VCARE MEDIUM UTERINE MANIPULATOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CONMED CORPORATION 60-6085-201A 201904221

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR