BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK TI-MAX

    MDR report key: 4425324 · Received January 7, 2015

    Report

    Report Number
    9611253-2015-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Report Date
    June 13, 2016
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, NSK AMERICA CORPORATION WAS MADE AWARE THAT A PATIENT MAY HAVE BEEN BURNED BY A NSK ELECTRIC DENTAL HANDPIECE. THE HANDPIECE WAS RECEIVED AT NSK AMERICA ON DECEMBER 11, 2014 AND RETURNED TO THE MANUFACTURER ON (B)(4) 2014. A LETTER WAS SENT TO THE DENTIST ON DECEMBER 9, 2014 REQUESTING ADDITIONAL INFORMATION. RECEIPT WAS CONFIRMED (B)(6) 2014. A SECOND LETTER WAS SENT ON DECEMBER 30, 2014. AS OF THE DATE OF THIS REPORT NO RESPONSE TO ANY REQUESTS FOR INFORMATION HAVE BEEN RECEIVED. NSK AMERICA HAS BEEN REQUESTING ADDITIONAL INFORMATION FROM THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11546 NSK TI-MAX HANDPIECE, CONTRA-ANDRIGHT - ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. X95L

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR