BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1716699 · Received June 8, 2010

    Report

    Report Number
    1032227-2010-00010
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    NSK TOCHIGI-KEN (JAPAN)
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE OFFICE ADVISED THAT THE HANDPIECE GOT HOT AND BURNED PT'S TONGUE WHILE DOING A CROWN PREP ON TOOTH #20. EVENT HAPPENED AT THE BEGINNING OF THE CROWN PREP. BURN WAS OVAL SHAPE. OFFICE ADVISED THAT THE BURN TURNED WHITE AND EVENTUALLY TURNED TO RED, AND NO MEDICAL ATTENTION WAS GIVEN. FOLLOW UP WITH OFFICE NOTED BURN WAS WHITE PATCHY AREA ABOUT ONE (1) INCH BY ONE-QUARTER (1/4) INCH. OFFICE ADVISED PT THAT PLACING ORAJEL ON THE BURN WOULD HELP WITH THE PAIN AND ALLOW FOR BETTER HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMAX EGS NSK TOCHIGI-KEN (JAPAN) X95L

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other