BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 1280806 · Received December 31, 2008

    Report

    Report Number
    1032227-2008-00011
    Event Type
    Malfunction
    Date Received
    December 31, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 17, 2008
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTIST NOTED PATIENT HAD BURN BLISTER TO INSIDE LIP (ANTERIOR REGION) AFTER CROWN PREPARATION. TREATMENT FOR BURN WAS PERIDEX RINSE.

    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 46 YR