BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1569896 · Received December 31, 2009

    Report

    Report Number
    1032227-2009-00064
    Event Type
    Injury
    Date Received
    December 31, 2009
    Report Date
    December 10, 2009
    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 REPORTED HANDPIECE OVERHEATING AND HAD BURNED A PATIENT BEFORE. WHEN CONTACTED FOR ADDITIONAL INFORMATION, THE DENTIST ADVISED THAT THE HANDPIECE OVERHEATED OVER A YEAR AGO AND HAD BLISTERED A PATIENT. THE DENTIST ADVISED THAT THE BLISTER HEALED ON ITS OWN WITH NO MEDICAL ATTENTION. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THERE IS NO RECORD OF HANDPIECE BEING SENT IN FOR REPAIR OR SERVICE.

    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 Other