BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 539115 · Received August 12, 2004

    Report

    Report Number
    2020601-2004-00003
    Event Type
    Injury
    Date Received
    August 12, 2004
    Date of Event
    July 12, 2004
    Report Date
    August 11, 2004
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    DWI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    MICROAIRE RECEIVED A REPORT THAT A PT RECEIVED AN UNSPECIFIED BURN IN THE MOUTH AREA, DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE HIGH SPEED DRILL DWI MICROAIRE SURGICAL INSTRUMENTS 6130 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other