BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 440572 · Received January 28, 2003

    Report

    Report Number
    2020601-2002-00004
    Event Type
    Injury
    Date Received
    January 28, 2003
    Date of Event
    December 16, 2002
    Report Date
    January 27, 2003
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    DZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MICROAIRE RECEIVED A REPORT CLAIMING THAT THE DRILL OVER HEATED DURING USE. THE DOCTOR STATED THAT HE HEARD DECREASING MOTOR SPEED AND ASSUMED THAT THE NITROGEN TANK WAS EMPTY, HOWEVER WHEN HE REMOVED THE DRILL, HE REALIZED THAT THE DEVICE WAS ABNORMALLY HOT AT THE NOSE AND THEN HE NOTICED THAT THE PATIENT HAD AN UNSPECIFICED BURN ON THE LOWER LEFT LIP. THE DOCTOR APPLIED "WHITE PETROLEUM JELLY" TO THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE HIGH SPEED DRILL DZI MICROAIRE SURGICAL INSTRUMENTS, INC. 2910-200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention