BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1509024 · Received October 15, 2009

    Report

    Report Number
    1032227-2009-00049
    Event Type
    Injury
    Date Received
    October 15, 2009
    Date of Event
    March 1, 2008
    Report Date
    March 4, 2008
    Manufacturer
    NSK TOCHIGI-KEN (JAPAN)
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED DEVICE OVERHEATING AND BURNED PATIENT, LEFT A BLISTER ON PATIENTS LIP. WHEN CONTACTED, OFFICE PROVIDED NO ADDITIONAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other