BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 1397321 · Received June 2, 2009

    Report

    Report Number
    1032227-2009-00016
    Event Type
    Malfunction
    Date Received
    June 2, 2009
    Report Date
    October 1, 2008
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING CONVERSATION, DENTIST REPORTED HANDPIECE BURNED A PT. DENTAL OFFICE CONTACTED ON 11/10/2008, 11/25/2008, 12/16/2008, 02/17/2009, AND 03/26/2009 TO OBTAIN ADDITIONAL INFO REGARDING DETAILS OF INCIDENT, BUT NONE RECEIVED.

    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