BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 1280803 · Received December 31, 2008

    Report

    Report Number
    1032227-2008-00008
    Event Type
    Malfunction
    Date Received
    December 31, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 1, 2008
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS FILLING A CAVITY. DENTIST ADVISED INJURY NOTED RIGHT AFTER PROCEDURE. INJURY WAS TO LEFT DORSAL SIDE OF TONGUE. TISSUE WAS WHITE. DENTIST ADMINISTERED OINTMENT FOR BURN. DURING ROUTINE FOLLOW UP, DENTIST GAVE PATIENT MORE OINTMENT FOR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMAX EGS NSK TOCHIGI-KEN TI-95L

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR