BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1508975 · Received October 15, 2009

    Report

    Report Number
    1032227-2009-00042
    Event Type
    Injury
    Date Received
    October 15, 2009
    Date of Event
    October 1, 2007
    Report Date
    October 16, 2007
    Manufacturer
    SK TOCHIGI-KEN (JAPAN)
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED HANDPIECE BURNT PT'S TONGUE. WHEN CONTACTED, DENTIST NOTED BURN PT'S CHEEK AND CLINICAL PROCEDURAL DELAY OF ABOUT 1 MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMAX EGS SK TOCHIGI-KEN (JAPAN) TI95L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other