BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1642752 · Received March 25, 2010

    Report

    Report Number
    1032227-2010-00002
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Manufacturer
    NSK TOCHIGI-KEN
    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 ADVISED HANDPIECE BURNED PT CHECK AND TONGUE. BURNED AREA WAS WHITE ON RIGHT CHECK SIDE, AND WHITE PATCH ON TONGUE ABOUT THE SIZE OF A DIME. DENTIST RECOMMENDED SALT WATER RINSE. LATER CONTACT WITH THE DENTIST NOTED THAT PAIN MEDICATIONS WERE PRESCRIBED FOR THE PT, BUT NO OTHER FOLLOW UP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other