BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 1509034 · Received October 15, 2009

    Report

    Report Number
    1032227-2009-00044
    Event Type
    Malfunction
    Date Received
    October 15, 2009
    Date of Event
    November 1, 2007
    Report Date
    November 29, 2007
    Manufacturer
    NSK TOCHIGI-KEN (JAPAN)
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED HANDPIECE OVERHEATING AND BURNT TWO PATIENTS CHEEKS. ATTEMPTED TO CONTACT OFFICE FOR ADDITIONAL INFO, BUT PERSONNEL WERE UNAVAILABLE UNTIL 10/19/2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMAX EGS NSK TOCHIGI-KEN (JAPAN) TI85L

    Patients

    Seq Age Sex Outcome Treatment
    1