BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMAX

    MDR report key: 1839850 · Received September 8, 2010

    Report

    Report Number
    9611253-2010-00031
    Event Type
    Injury
    Date Received
    September 8, 2010
    Report Date
    May 18, 2009
    Manufacturer
    NSK
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS SHOWED NO PROBLEMS WITH MATERIALS, MANUFACTURE, OR TEST OF SUBJECT DEVICE. RETURNED DEVICE WAS DISASSEMBLED AND EXAMINED. DAMAGE WAS OBSERVED IN BEARING ASSEMBLY, CAUSING OVERHEATING AND INDICATING IMPROPER USER MAINTENANCE (CLEANING/LUBRICATION). DEVICE WAS REPAIRED TO ORIGINAL MANUFACTURING SPECIFICATIONS. TESTS AFTER REPAIR SHOWED NO OVERHEATING.

    Description of Event or Problem · 1

    ON INITIAL CONTACT, DENTIST REPORTED HANDPIECE OVERHEATING, GETTING HOT AND BURNED PATIENT. OFFICE WAS CONTACTED ON 06/03/2009, 06/06/2009, 06/09/2009 AND 06/18/2009 TO OBTAIN ADDITIONAL INFORMATION, BUT UNABLE TO OBTAIN INFORMATION AND DETAILS REGARDING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMAX EGS NSK TI95L

    Patients

    Seq Age Sex Outcome Treatment
    1