BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK TIMAX NL 400U ELECTRIC HANDPIECE

    MDR report key: 1011349 · Received March 12, 2008

    Report

    Report Number
    MW5005848
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    September 11, 2007
    Report Date
    March 12, 2008
    Manufacturer
    BRASSLER
    Product Code
    EKX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REPORTER WAS WORKING ON A PT AND THE HANDPIECE BECAME SO HOT THAT IT BURNED THE PT. THE PT'S TONGUE WAS BEHIND A RUBBER DAM SO REPORTER WAS UNAWARE THAT BURN WAS OCCURRING. BURNS WERE 2ND DEGREE WITH BLISTERING AND SLOUGHING. THE PT COULDN'T TALK OR SWALLOW WITHOUT SEVERE PAIN FOR 2 WEEKS. REPORTER HAD TO GIVE THE DENTAL WORK AWAY AND MFR TAKES NO RESPONSIBILITY FOR THE INCIDENT NEITHER WILL THEY SERVICE DEVICE OR SEND A SALES REP. APPARENTLY, WITH PROPER MAINTENANCE THIS SHOULD NOT OCCUR, BUT REPORTER WAS NEVER GIVEN THOSE INSTRUCTIONS BY MFR. THESE DEVICES TOOK THE PLACE OF AIR-DRIVEN HANDPIECES THAT DID NOT GET HOT WHEN THEY FAILED, BUT REPORTER WAS NEVER TOLD THAT THESE NEW DEVICES WORK IN A DIFFERENT WAY THAN THE AIR-DRIVEN AND THEREFORE, DO GET HOT WHEN THEY FAIL. THIS INCIDENT HAPPENED WITHIN THE FIRST MONTH OF PURCHASE OF DEVICE AND REPORTER HAS NOT EVEN PAID FOR IT. REPORTER PLANS TO RETURN DEVICE TO MFR. REPORTER UNDERSTANDS THIS IS HAPPENING THROUGHOUT THE DENTAL COMMUNITY BECAUSE OF READING ABOUT IT IN A DENTAL PERIODICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NSK TIMAX NL 400U ELECTRIC HANDPIECE ELECTRIC DENTAL HANDPIECE EKX BRASSLER NE161 NA

    Patients

    Seq Age Sex Outcome Treatment
    1