BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE

    MDR report key: 1251463 · Received August 21, 2008

    Report

    Report Number
    1320894-2008-00124
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    May 21, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN I RECEIVE THE INVESTIGATION REPORT, I WILL FILE A SUPPLEMENTAL REPORT. THE HOSPITAL HAS ALREADY FILED A MEDWATCH REPORT REGARDING THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE CUP WHICH WAS INSERTED INTO THE CERVIX MELTED DURING SURGERY." NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *