BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MAX

    MDR report key: 1280804 · Received December 31, 2008

    Report

    Report Number
    1032227-2008-00009
    Event Type
    Malfunction
    Date Received
    December 31, 2008
    Report Date
    September 19, 2008
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DOCTOR RETURNED UNIT FOR REPAIR INDICATING IT HAD BURNED A PATIENT'S MOUTH. AFTER CALLS ON 11/26, 12/3 AND 12/09, WE HAVE NOT BEEN ABLE TO OBTAIN MORE INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1