BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 1280807 · Received December 31, 2008

    Report

    Report Number
    1032227-2008-00012
    Event Type
    Malfunction
    Date Received
    December 31, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 30, 2008
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING CAVITY PREPARATION, DENTIST NOTED MINOR BURNS IN LOWER RIGHT QUADRANT. DENTIST TOLD PATIENT TO PUT OINTMENT ON BURN AND FOLLOWED UP WITH PHONE CALL TO PATIENT TO MAKE SURE PATIENT WAS OK.

    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 70 YR