BEUDAMED
    FDA Adverse Event Summary report: N

    NSK

    MDR report key: 4378886 · Received December 18, 2014

    Report

    Report Number
    9611253-2014-00036
    Date Received
    December 18, 2014
    Report Date
    December 18, 2014
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2014 NSK AMERICA CORP. RECEIVED AN ELECTRIC DENTAL HANDPIECE, MODEL X95L, SERIAL (B)(4) FOR REPAIR FROM A DISTRIBUTOR REPAIR FACILITY. ON THE DISTRIBUTOR'S DOCUMENTATION WAS THE STATEMENT: "SMOKE OUT OF BACK, DR CLAIMS PATIENT BURNED - SEE DR'S NOTE ATTACHED." INCLUDED WITH THE PAPER WORK WAS A HAND-WRITTEN POST-IT NOTE THAT READ, 'I SAW SMOKE POOF OUT OF THE BACK OF A HANDPIECE WHILE TRIMMING A TEMP. I WASN'T QUITE SURE WHAT HAPPENED. I DID NOT PULL THE [HANDPIECE]. A FEW DAYS LATER MY [PATIENT] HAD A BURN? ON THE INSIDE OF HER CHEEK LIKE WHERE THE HEAD OF THE [HANDPIECE] WOULD REST. THIS IS THAT HANDPIECE. I DON'T KNOW IF IT IS THE ONE THAT SMOKED BUT I'M THINKING SOMETHING IS WRONG WITH THIS ONE." THE HANDPIECE WAS FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION ON (B)(4) 2014. LETTERS REQUESTING ADDITIONAL DETAILS SURROUNDING THE REPORTED EVENT WERE SENT TO THE DENTIST ON (B)(6) 2014 AND (B)(6) 2014. NSK AMERICA HAS MADE THE REQUESTS FOR ADDITIONAL INFORMATION FROM THE COMPLAINANT. AS OF THIS REPORT, NO ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832839 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. X95L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other