BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO 100 DRILL

    MDR report key: 247939 · Received October 22, 1999

    Report

    Report Number
    1017294-1999-00045
    Event Type
    Other
    Date Received
    October 22, 1999
    Date of Event
    September 13, 1999
    Report Date
    September 14, 1999
    Manufacturer
    LINVATEC CORP.
    Product Code
    DZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A MAXILLOFACIAL REPAIR THE BUR GUARD BECAME WARM AND THEN HOT. THE HANDPIECE DID NOT GET HOT. 'THE BUR GUARD BEARINGS BECAME WORN, COULD NOT RULE OUT OPERATOR ERROR.' MOUTH GAG WAS BEING USED. MINOR BURN TO INSIDE OF CHEEK 1/2 X 1 1/2 CM AND TO CENTER BOTTOM LIP <1 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO 100 DRILL DRILL DZI LINVATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other