BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE

    MDR report key: 1071564 · Received June 30, 2008

    Report

    Report Number
    1071564
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    April 15, 2008
    Report Date
    June 30, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE MANIPULATING THE UTERUS WITH THE DEVICE, THE BALLOON FAILED AND THIS MAY HAVE CAUSED THE DEVICE TO COME APART AND THE CERVICAL CAP TO REMAIN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION 60-6085 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR