BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO-EXPRESS

    MDR report key: 1250879 · Received July 2, 2008

    Report

    Report Number
    2433629-2008-00002
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    January 30, 2007
    Report Date
    July 2, 2008
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EKA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR USED A DENTAL HANDPIECE ON THE PT AND THE HANDPIECE OVERHEATED. NO ONE WAS INJURED. REF MFR# 9611253-2008-00001, IMP# (B)(4), MW5007345, MW5007346.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO-EXPRESS DENTAL HANDPIECE EKA NAKANISHI, INC. (NSK) TEP-E4R *

    Patients

    Seq Age Sex Outcome Treatment
    1 *