BEUDAMED
    FDA Adverse Event Other Summary report: N

    VALLEY LAB ELECTROCAUTERY DEVICE

    MDR report key: 531300 · Received May 26, 2004

    Report

    Report Number
    531300
    Event Type
    Other
    Date Received
    May 26, 2004
    Date of Event
    May 20, 2004
    Report Date
    May 20, 2004
    Manufacturer
    VALLEYLAB/DIVISION OF TYCO HEALTHCARE GROUP
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE INCH LONG BOVIE BURN NOTED ON PT'S ABDOMEN BELOW THE UMBILICUS. FIRST DEGREE IN NATURE. SILVADENE APPLIED TO AREA. PER OPERATING ROOM STAFF, THE ELECTROCAUTERY EQUIPMENT "MALFUNCTIONED." EQUIPMENT BEING EXAMINED BY BIOMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEY LAB ELECTROCAUTERY DEVICE ELECTROCAUTERY DEVICE GEI VALLEYLAB/DIVISION OF TYCO HEALTHCARE GROUP 4SXC *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other