BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 6193971 · Received December 21, 2016

    Report

    Report Number
    9611253-2016-00075
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    December 12, 2016
    Report Date
    June 15, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NAKANISHI TOOK THE FOLLOWING ACTIONS TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT, THE PATIENT AND THE PRODUCTION SERIAL NUMBER, AND WHETHER OR NOT THE DEVICE INVOLVED IN THE EVENT WOULD BE RETURNED FOR INVESTIGATION. HOWEVER, NAKANISHI COULD NOT RECEIVE ANY OF THE INFORMATION. ON JUNE 26, 2017, NAKANISHI SENT AN EMAIL TO NUK FOR THE INFORMATION. NUK RETURNED AN EMAIL STATING THAT: 1) THERE WAS NO FURTHER INFORMATION ABOUT THE EVENT, THE PATIENT AND THE SERIAL NUMBER. 2) THE SUBJECT DEVICE HAD NOT BEEN/WOULD NEVER BE RETURNED FROM THE USER. ON NOVEMBER 16, 2017, NAKANISHI SENT AN EMAIL TO NUK FOR THE INFORMATION. THERE WAS NO INFORMATION AVAILABLE. ON JANUARY 18, 2018, NAKANISHI HAD A CONVERSATION WITH THE NUK MANAGER DURING HIS VISIT TO NAKANISHI. NUK DID NOT HAVE THE INFORMATION. SINCE NAKANISHI DID NOT RECEIVE THE SUBJECT DEVICE AND THE SERIAL NUMBER, NAKANISHI COULD NOT TAKE ANY INVESTIGATION APPROACH, INCLUDING DHR EXAMINATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN EUROPE, BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K112673. ON DECEMBER 14, 2016, NAKANISHI CONTACTED THE DISTRIBUTOR TO REQUEST PATIENT INFORMATION AND THE SERIAL NUMBER. NAKANISHI HAS NOT OBTAINED ANY INFORMATION AS OF THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, NAKANISHI RECEIVED INFORMATION FROM A DISTRIBUTOR ((B)(4)) DESCRIBING A PATIENT INJURY. DETAILS ARE AS FOLLOWS. - THE EVENT OCCURRED ON (B)(6) 2016. - THE PATIENT DEVELOPED SYMPTOMS OF EMPHYSEMA DURING TREATMENT WHILE THE DENTIST WAS USING AN NSK PERIO MATE HANDPIECE. - AS AN INITIAL RESPONSE, NSK UNITED KINGDOM PROVIDED MSDS TO THE DENTIST TO EXPLAIN THAT GLYCINE POWDER IS HIGHLY WATER-SOLUBLE, AND IT WILL NOT RETAIN IN THE SUBGINGIVAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844540 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. PER-PTL-P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other