BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALL SURGICAL BUR GUARD

    MDR report key: 780991 · Received November 10, 2006

    Report

    Report Number
    1017294-2006-00470
    Event Type
    Other
    Date Received
    November 10, 2006
    Report Date
    October 13, 2006
    Manufacturer
    CONMED LINVATEC
    Product Code
    EQJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE BUR GUARD WAS RECEIVED FOR EVAL AND UNABLE TO BE TESTED DUE TO DAMAGE OF THE INNER RACE OF THE BEARING. OVERHEATING OF THE BUR GUARD CAN OCCUR WITH THIS TYPE OF FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN AN ORAL SURGICAL PROCEDURE THE DRILL GOT HOT AND BURNT THE PT'S LIP. THE SURGEON RECOMMENDED THE PT APPLY OINTMENT TO THE AFFECTED AREA. IT WAS REPORTED THAT THE PT WAS SEEN ON FOLLOW UP EXAMINATION AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL SURGICAL BUR GUARD BUR GUARD EQJ CONMED LINVATEC NA JUL06S

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other HALL SURGAIRTOME TWO DRILL, CATALOG#: 00505800100