BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1569898 · Received December 31, 2009

    Report

    Report Number
    1032227-2009-00065
    Event Type
    Injury
    Date Received
    December 31, 2009
    Date of Event
    November 24, 2009
    Report Date
    December 18, 2009
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED HANDPIECE OVERHEATING. DENTIST ADVISED THAT HE / SHE FINISHED THE PROCEDURE. DENTIST NOTICED AFTERWARD THAT THE PATIENT'S MOUTH HAD BEEN BURNED FROM BACK TO FRONT, INCLUDING A BLISTER THAT WAS NOTED TO BE ALMOST A 3RD DEGREE BURN. NO MEDICAL INTERVENTION WAS DONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other