BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 4992212 · Received August 10, 2015

    Report

    Report Number
    9611253-2015-00104
    Event Type
    Injury
    Date Received
    August 10, 2015
    Date of Event
    May 14, 2013
    Report Date
    July 16, 2015
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EFB
    PMA / PMN Number
    K962543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE INFORMATION, NAKANISHI REVIEWED THE MANUFACTURING AND SHIPPING RECORDS OF THE HANDPIECE INVOLVED IN THE EVENT. THERE WERE NO SUCH RECORDS FOR ANY HANDPIECE WITH THAT SERIAL NUMBER IN NSK FILES. NAKANISHI COULD NOT IDENTIFY THE DEVICE AS A HANDPIECE NAKANISHI ACTUALLY MANUFACTURED AND SHIPPED. (B)(4). HOWEVER, WE COULD NOT CONFIRM IN ANY SHIPPING RECORD THAT NSK SHIPPED IT TO THE USA. CHINESE-MADE COUNTERFEIT COPIES OF THIS PRODUCT WERE CIRCULATING FOR THE SUBJECT MODEL, AND THE SUBJECT PRODUCT CANNOT BE RETURNED DUE TO THE LAWSUIT. THEREFORE, WE CANNOT DEFINITIVELY DETERMINE IT IS AN NSK PRODUCT OR NOT WITHOUT OBSERVING THE ACTUAL PRODUCT. IN THIS CASE, WE CANNOT AFFIRM THAT "IT IS AN NSK PRODUCT" BASED ON THE INVESTIGATION RESULTS MENTIONED ABOVE, BUT NSK DETERMINES THAT IT IS MDR REPORTABLE BY SAYING THAT "IT MAY BE AN NSK PRODUCT."

    Description of Event or Problem · 1

    ON (B)(6) 2015 NAKANISHI RECEIVED AN EMAIL FROM NSK AMERICA ADVISING THEY HAD RECEIVED INFORMATION THAT A DENTIST HAD INJURED A PATIENT THROAT WITH AN NSK HANDPIECE, (B)(4). DETAILS ARE AS FOLLOWS: ON (B)(6) 2013 THE DENTIST PROVIDED THE PATIENT WITH A DENTAL TREATMENT. DURING THE TREATMENT, A PIECE OF THE EQUIPMENT (BUR) BEING USED FELL OFF THE HANDPIECE INTO THE PATIENT'S THROAT. AS A RESULT, THE PATIENT SUFFERED PERSONAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523205 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI, INC. CH45-QD-SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other