BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 12678913 · Received October 22, 2021

    Report

    Report Number
    9611253-2021-00059
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    May 1, 2011
    Report Date
    November 5, 2021
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE THE FOLLOWING ACTIONS, NAKANISHI DID NOT RECEIVE FURTHER INFORMATION ABOUT THE EVENT, INCLUDING INFORMATION ABOUT THE PATIENT. - ON OCTOBER 19, 2021, NAKANISHI SENT AN EMAIL TO THE DISTRIBUTOR REQUESTING INFORMATION MISSING FROM THE INITIAL REPORT. - ON NOVEMBER 1, 2021, NAKANISHI RECEIVED A REPLY FROM THE DISTRIBUTOR STATING THAT THERE WAS NO OTHER INFORMATION THEY COULD PROVIDE ABOUT THE EVENT.

    Additional Manufacturer Narrative · 1

    NAKANISHI IS TRYING TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT, INCLUDING INFORMATION ABOUT THE PATIENT.

    Description of Event or Problem · 1

    ON SEPTEMBER 30, 2021, NAKANISHI RECEIVED A LETTER FROM A DISTRIBUTOR (DENTALEZ INC.) ABOUT AN NSK HANDPIECE OVERHEATING. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2011. THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE X95L STD HANDPIECE (SERIAL NO.: (B)(4)). DURING THE PROCEDURE, THE HANDPIECE HEAD OVERHEATED AND BURNED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580224 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. X85L STD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other