BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL VUE

    MDR report key: 19460 · Received February 7, 1995

    Report

    Report Number
    MW1005013
    Event Type
    Malfunction
    Date Received
    February 7, 1995
    Date of Event
    January 9, 1995
    Report Date
    January 10, 1995
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIGHT SOURCE, SUCTION AND IRRIGATION WERE SET UP AND USED DURING PROCEDURE. DURING LARGE PORTION OF PROCEDURE, DEVICE WAS NOT USED, AND WAS PLACED ON DRAPED ABDOMEN WHERE IT REMAINED TURNED ON. AFTER THE PROCEDURE, PT WAS FOUND TO HAVE A 5 MM X 2 MM BURN ON SKIN OF ABDOMEN. NO EVIDENCE OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL VUE LIGHT, SUCTION AND IRRIGATION MACHINE JCX DAVIS & GECK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR