BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDWEST TRADITION

    MDR report key: 5322250 · Received December 23, 2015

    Report

    Report Number
    5322250
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    October 20, 2015
    Report Date
    December 10, 2015
    Manufacturer
    DENTSPLY INTERNATIONAL INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DENTIST WAS USING MIDWEST DENTAL DRILL HANDPIECE ATTACHED TO PEDS DENTAL CONSOLE. AFTER PERIOD OF PROLONGED AND HEAVY USE THE DENTIST NOTED SMOKE EMANATING FROM THE CONNECTION BETWEEN THE HANDPIECE AND THE TUBING. A NEW HAND PIECE WAS CONNECTED WITHOUT THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848408 MIDWEST TRADITION HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY INTERNATIONAL INC. 780045

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR