BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 3804301 · Received April 9, 2014

    Report

    Report Number
    3804301
    Date Received
    April 9, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    NSK AMERICA CORP
    Product Code
    EKX
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS DRILLING IN THE PATIENT'S MOUTH (RIGHT MANDIBLE). THE DRILL OVERHEATED CAUSING A BURN TO THE PATIENT'S LIP. DURING THE OSTECTOMY THE SURGEON NOTICED THE HAND PIECE OF THE DRILL BECAME UNUSUALLY HOT. HE STOPPED THE PROCEDURE ONLY TO DISCOVER A BURN HAD OCCURRED ON THE RIGHT MUCOSAL SURFACE OF THE LIP ASSOCIATED WITH THIS EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213395 * DENTAL DRILL EKX NSK AMERICA CORP M4B-28970 *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR