BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 23663085 · Received November 26, 2025

    Report

    Report Number
    9611253-2025-00059
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 25, 2025
    Report Date
    February 3, 2026
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    UDI-DI
    04064797028155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE SOFT PEARL CLEANING POWDER AND THE MANUFACTURING RECORD FROM THE MANUFACTURER OF THE SOFT PEARL CLEANING POWDER, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED CLEANING POWDER [REPORT NO. (B)(4)]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE MANUFACTURING RECORD PROVIDED BY THE MANUFACTURER FOR THE SUBJECT SOFT PEARL CLEANING POWDER [LOT NO. A0574]. THE RECORD CONFIRMED THAT NO PROBLEMS WERE IDENTIFIED DURING MANUFACTURING AND TESTING. B) NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED CLEANING POWDER AND OBSERVED NO DISCOLORATION OR ABNORMALITIES IN THE POWDER'S APPEARANCE. C) FT IR ANALYSIS WAS ALSO PERFORMED AND COMPARED WITH NAKANISHI'S IN STOCK SAMPLE (LOT NO. A2713), BUT NO DIFFERENCES WERE OBSERVED IN THE IR SPECTRUM. B) NAKANISHI ALSO CONFIRMED THE OPERATION MANUAL STATING THAT THE SOFT PEARL CLEANING POWDER MUST NOT BE USED IF THE PATIENT IS GLYCINE SENSITIVE. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: A) NAKANISHI CONSIDERS THAT THE POSSIBLE CAUSE OF THE REPORTED ADVERSE EVENT WAS THE USE OF SOFT PEARL CLEANING POWDER IN A PATIENT WITH AN ALLERGY TO GLYCINE. B) IN ORDER TO PREVENT A RECURRENCE OF THE REPORTED EVENT, NAKANISHI TOOK THE FOLLOWING ACTIONS: B.1) NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED THE CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. B.2) NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DENTAL HYGIENIST AND REMIND THE DENTAL HYGIENIST OF THE IMPORTANCE OF USING THE CLEANING POWDER AS INSTRUCTED IN THE OPERATION MANUAL.

    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 WEIGHT. NAKANISHI IS STILL TRYING TO OBTAIN THE MANUFACTURING RECORDS FROM THE MANUFACTURER OF THE SOFT PEARL CLEANING POWDER.

    Description of Event or Problem · 0

    ON OCTOBER 31, 2025, NAKANISHI RECEIVED A PHONE CALL FROM A DEALER ABOUT A MALFUNCTION OF AN NSK CLEANING POWDER. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2025. THE DENTAL HYGIENIST WAS CLEANING THE TEETH AROUND THE PATIENT'S BRACES USING THE PROPHY-MATE NEO AND THE SOFT PEARL CLEANING POWDER (LOT NO. A0574). AFTER THE PROCEDURE, THE DENTAL HYGIENIST NOTICED THAT THE RIGHT SIDE OF THE PATIENT'S FACE WAS SWOLLEN. THE PATIENT IS EXPECTED TO BE HEALED NORMALLY WITHOUT NEED FOR ANY FURTHER MEDICAL TREATMENT. ACCORDING TO THE DENTIST, THERE WERE NO ABNORMALITIES OBSERVED IN THE DEVICE PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120618 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. SOFT PEARL A0574 04064797028155

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other