BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 22067105 · Received May 21, 2025

    Report

    Report Number
    9611253-2025-00020
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 21, 2025
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED IN JAPAN, BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K112673. THE DENTIST REFUSED TO PROVIDE INFORMATION ABOUT THE PATIENT'S AGE, WEIGHT, RACE, AND ETHNICITY. ACCORDING TO THE DEALER, FURTHER INSPECTION OF THE HANDPIECE INVOLVED IN THE ADVERSE EVENT FOR CAUSE BY NAKANISHI IS NO LONGER POSSIBLE BECAUSE THE DENTIST REFUSED TO RETURN THE HANDPIECE TO NAKANISHI FOR THE INVESTIGATION. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI EXAMINED THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT PERIO-HP DEVICE [SERIAL NO. (B)(6)]. AS A RESULT OF THE EXAMINATION, THE DHR INDICATED THAT NO PROBLEMS OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    ON APRIL 23, 2025, NAKANISHI RECEIVED A PHONE CALL FROM A DEALER ABOUT A MALFUNCTION OF AN NSK HANDPIECE. UPON RECEIPT OF THE INFORMATION, NAKANISHI VISITED THE DENTAL OFFICE FOR FURTHER INFORMATION ABOUT THE EVENT INCLUDING INFORMATION ABOUT THE PATIENT. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS: - THE EVENT OCCURRED ON (B)(6) 2025. - THE DENTIST WAS CLEANING THE TEETH OF A PATIENT USING THE PERIO-HP HANDPIECE (SERIAL NO. (B)(6)) AND THE CLEANING POWDER. - DURING THE PROCEDURE, THE PATIENT COMPLAINED OF FEELING PAIN. - THE DENTIST NOTICED THAT A SUBCUTANEOUS EMPHYSEMA WAS IN THE LYMPHATIC AREA OF THE PATIENT'S CHEEK. - THE DENTIST PRESCRIBED AN ANTIBIOTIC TO THE PATIENT AND RECOMMENDED THE PATIENT TO SEE AN OTOLARYNGOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220436 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. PERIO-HP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other