BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE

    MDR report key: 1112127 · Received August 6, 2008

    Report

    Report Number
    1320894-2008-00118
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 6, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN I RECEIVE THE INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHITE HANDLE BECAME LOOSE AND ROTATES, STOPPING UTERINE MANIPULATION DURING A LAVH.''

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION NA 0706151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK