BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE MEDIUM, VAGINAL-CERVICAL-AHLUWALLA'S-RETRACTOR-ELEVATOR UTERINE MANIPULATO

    MDR report key: 8723578 · Received June 20, 2019

    Report

    Report Number
    MW5087534
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    June 17, 2019
    Report Date
    June 18, 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-AHLUWALLA'S-RETRACTOR-ELEVATOR, WOULD NOT HOLD AIR IN THE BALLOON. DEVICE REMOVED FROM THE SURGICAL FIELD AND REPLACED WITH ANOTHER "LIKE" DEVICE WITH NO FURTHER ISSUES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509096 VCARE MEDIUM, VAGINAL-CERVICAL-AHLUWALLA'S-RETRACTOR-ELEVATOR UTERINE MANIPULATO CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CONMED CORPORATION 60-6085-201A 201904221

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR