BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK ELECTROSURGICAL PENCIL

    MDR report key: 697163 · Received April 5, 2006

    Report

    Report Number
    1717344-2005-00050
    Event Type
    Malfunction
    Date Received
    April 5, 2006
    Date of Event
    November 16, 2004
    Report Date
    February 17, 2005
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: TONSILLECTOMY. REPORTEDLY, WHILE IN THE OR FOR A TONSILLECTOMY THE PT RECEIVED A BURN ON THE RIGHT CORNER OF THE MOUTH. THE CAUTERY BURNED THROUGH THE PROTECTIVE SHEATH ON THE BOVIE PENCIL. TREATED WITH NEOSPORIN CREAM. NOTE: THIS REPORT IS IN RESPONSE TO A LETTER DATED 1/19/2005 AND RECEIVED BY OUR OFFICE ON 2/28/2005 REFERENCING REPORT #MW1034151. PLEASE SEE SECTION H11 FOR ANSWERES TO YOUR QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ELECTROSURGICAL PENCIL * GEI VALLEYLAB * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN