BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERIDAN ET TUBE

    MDR report key: 15342 · Received January 5, 1994

    Report

    Report Number
    36484-1993-00001
    Event Type
    Injury
    Date Received
    January 5, 1994
    Date of Event
    October 19, 1993
    Report Date
    December 8, 1993
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Code
    BSK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DOCTOR HAD BEEN USING AN ELECTRO-SURGICAL PEN ON THE PT. NEXT TO WHERE AN ENDO TRACHEAL TUBE WAS IN PLACE. THE TUBE CAUGHT FIRE CAUSING SERIOUS INJURY TO THE PT WHEN A SPARK FROM THE PEN TOUCHED THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERIDAN ET TUBE ENDO-TRACHEAL TUBE BSK SHERIDAN CATHETER CORP. 10313 9103G000732

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| L