BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE

    MDR report key: 1093263 · Received July 28, 2008

    Report

    Report Number
    1093263
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 28, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON HAD TO MANUALLY EXTRACT V-CARE CUP FROM THE CERVICAL OS. PATIENT REMAINED STABLE; NO ISSUES RELATED TO REMOVING MANIPULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION --- 0803121

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR