BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1569897 · Received December 31, 2009

    Report

    Report Number
    1032227-2009-00063
    Event Type
    Injury
    Date Received
    December 31, 2009
    Date of Event
    December 2, 2009
    Report Date
    December 3, 2009
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED HANDPIECE OVERHEATING AND BURNED PATIENT. DENTIST NOTED A QUARTER SIZE BURN ON TONGUE AFTER PROCEDURE TO REMOVE AMALGAM FORM LOWER SECOND MOLAR. DENTIST CHECKED ON PATIENT NEXT DAY. DENTIST NOTED HE DID NOT LUBRICATE ATTACHMENTS NOR DO ANYTHING FOR MAINTENANCE. AFTER THE PROCEDURE, DENTIST ADVISED HE RAN THE HANDPIECE FOR A SHORT TIME (10-15 SECONDS) AND THEN PUT IT ON THE INSIDE OF HIS OWN WRIST, CAUSING A BURN THERE.

    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 57 YR Other