BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 1490639 · Received October 1, 2009

    Report

    Report Number
    1032227-2009-00022
    Event Type
    Malfunction
    Date Received
    October 1, 2009
    Report Date
    May 18, 2009
    Manufacturer
    NSK TOCHIGI-KEN (JAPAN)
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED HANDPIECE OVERHEATING, GETTING HOT AND BURNED PATIENT. OFFICE WAS CONTACTED ON 06/03/2009, 06/06/2009, 06/09/2009 AND 06/18/2009 TO OBTAIN ADDITIONAL INFORMATION, BUT UNABLE TO OBTAIN INFORMATION AND DETAILS REGARDING EVENT.

    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