BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHAGEAL/RECTAL TEMPERATURE PROBE

    MDR report key: 1055424 · Received May 22, 2008

    Report

    Report Number
    1221261-2008-00019
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BZT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THEY WERE USING THE DEVICE DURING A CERVICAL SPINE SURGERY WITH A POSTERIOR APPROACH WITH THE PT IN MAYFIELD TONGS USING ELECTROCAUTERY SURGERY. THE PT RECEIVED 3RD DEGREE BURNS ON HIS PALATE. THE ACTIVE ELECTRODE WAS USED ON THE "BACK OF THE NECK" AND THE GROUND ELECTRODE WAS A FEW INCHES LOWER ON THE POSTERIOR OF THE PT. THE PT WAS UNDER GENERAL ANESTHESIA AND WAS INTUBATED WITH A TRADITIONAL ET TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHAGEAL/RECTAL TEMPERATURE PROBE 73BZT ESOPHAGEAL BZT SMITHS MEDICAL ASD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention ENDOTRACHEAL TUBE