BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 1559677 · Received December 10, 2009

    Report

    Report Number
    1032227-2009-00061
    Event Type
    Malfunction
    Date Received
    December 10, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 19, 2009
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED HANDPIECE OVERHEATING AND BURNED PT. DENTIST NOTED QUARTER SIZE BURN LEFT ON INSIDE OF THE LOWER RIGHT CHEEK OF PT DURING QUADRANT RESTORATION. DENTIST USED TOPICAL TREATMENT IN OFFICE.

    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 20 YR