BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE MEDIUM UTERINE MANIPULATOR

    MDR report key: 8555217 · Received April 25, 2019

    Report

    Report Number
    MW5086192
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 24, 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

    CONMED CORPORATION, VCARE MEDIUM, VAGINAL-CERVICAL-AHLUWALIAS-RETRACTOR-ELEVATOR, BALLOON WOULD NOT STAY INFLATED. PRIOR TO THE START OF THE PROCEDURE, THE BALLOON WAS TESTED PER PROTOCOL, AT WHICH TIME THE DEFECT WAS DISCOVERED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343756 VCARE MEDIUM UTERINE MANIPULATOR CANNULA, MANIPULATOR/ INJECTOR, UTERINE LKF CONMED CORPORATION 60-6085-201A 201903181

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR