BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 428139 · Received November 7, 2002

    Report

    Report Number
    428139
    Event Type
    Other
    Date Received
    November 7, 2002
    Date of Event
    September 23, 2002
    Report Date
    September 27, 2002
    Manufacturer
    VALLEYLAB DIV OF TYCO HEALTHCARE GRP
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ELECTROSURGERY UNIT AND DISPOSABLE PENCIL ACCESSORY STUCK IN "ON" OR "CUT" POSITION. BOVIE HAD BEEN PLUGGED IN AND LAID NEXT TO PT'S LEG. NOT BEING USED BY PHYSICIAN WHEN IT BEGAN TO BURN PT'S LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BOVIE ELECTROSURGERY UNIT & DISPOSABLE PENCIL GEI VALLEYLAB DIV OF TYCO HEALTHCARE GRP 40S-20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other