BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NKS PM-L

    MDR report key: 4805638 · Received May 26, 2015

    Report

    Report Number
    9611253-2015-00075
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    August 22, 2014
    Report Date
    May 21, 2015
    Manufacturer
    NAKANISHI INC. (NSK)
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE HANDPIECE WAS FORWARDED TO THE MANUFACTURER (NAKANISHI) FOR AN ANALYSIS AND INVESTIGATION ON (B)(6) 2014. THIS ADVERSE EVENT OCCURRED IN (B)(6), BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K032395. UPON RECEIPT FROM THE DENTIST OF THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE AS DESCRIBED BELOW: METHODOLOGY USED: NAKANISHI CONDUCTED "ADMIZING" TEST FOR SIX MINUTES ON TWO ACCEPTED HANDPIECES AND THE COMPLAINT HANDPIECE. NAKANISHI OBTAINED THE SAME RESULTS (NORMAL QUANTITY OF POWDER) FOR ALL. CONCLUSION REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NAKANISHI COULD NOT REPRODUCE THE PROBLEM, AND COULD NOT IDENTIFY THE CAUSE. NAKANISHI RETURNED THE PRODUCT TO THE USER AFTER OVERHAUL.

    Description of Event or Problem · 1

    THIS MDR IS BEING REPORTED AT THIS TIME AS PART OF OUR INTERNAL REVIEW OF PAST COMPLAINTS AND SERVICE RECORDS. DUE TO THE INCIDENT BEING IN THE PAST, NAKANISHI IS LIMITED IN THE INFO THAT CAN BE OBTAINED FROM THE INITIAL COMPLAINANT. EVENT SUMMARY: ACCORDING TO THE DIST, THE PT BECOMES "AERODERMECTASIA" DURING CLEANING OF THE TOOTH SURFACE WITH PROPHY MATE. THE DIST INFORMED NAKANISHI THAT THE PT HAD BEEN HOSPITALIZED. THE PT WAS DISCHARGED ON (B)(4) 2014. COMPLAINT REVIEW: THERE WERE NO PREVIOUS COMPLAINTS FOR THIS HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339909 NKS PM-L EFB NAKANISHI INC. (NSK) PM-L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other