BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUFRIEDYGROUP

    MDR report key: 23355416 · Received October 22, 2025

    Report

    Report Number
    3003933619-2025-70000
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    May 25, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MECTRON S.P.A.
    Product Code
    KOJ
    UDI-DI
    10889950142551
    PMA / PMN Number
    K231391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF PRODUCTION RECORDS NO ANOMALIES OR NON-CONFORMITIES EMERGED FROM THE REVIEW OF PRODUCT RELEASE CONTROL DATA. TREND ANALYSIS NO HISTORICAL RECORDS AVAILABLE OF SIMILAR EVENTS FOR THIS OR SIMILAR PRODUCT. CLINICAL EVALUATION & CONCLUSION DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE PATIENT DECLINED TO PROVIDE FURTHER DIAGNOSTIC DETAILS REGARDING THE SUSPECTED AIR EMBOLISM. THE ONLY AVAILABLE CLINICAL INFORMATION INCLUDES REPORTED SWELLING ON THE LEFT SIDE OF THE FACE, EYE, AND NECK. DUE TO THE LACK OF CONFIRMED MEDICAL DIAGNOSIS AND THE ABSENCE OF INSTRUMENTAL EVIDENCE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE NATURE OF THE ADVERSE EVENT. FURTHERMORE, BASED ON THE TECHNICAL EVALUATION AND THE AVAILABLE USAGE DATA, NO CAUSAL RELATIONSHIP CAN BE ESTABLISHED BETWEEN THE ADVERSE EVENT AND THE MEDICAL DEVICE OR ITS METHOD OF USE.

    Description of Event or Problem · 0

    A 80+ YEAR OLD PATIENT GOT AN AIR EMBOLISM DURING USE OF THE PWR PAIR.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE WERE INFORMED BY OUR DISTRIBUTOR HU-FRIEDY GROUP THAT A PATIENT OF ONE OF THEIR CUSTOMERS EXPERIENCED AN ADVERSE EVENT DURING A TREATMENT WITH THE DEVICE OBJECT OF THE PRESENT REPORT. FROM A FIRST NOTICE, THE PATIENT CONDITION REPORTED BY THE DENTIST WAS AIR EMBOLISM THAT OCCURRED AFTER SCALING TREATMENT FOLLOWED BY ABOUT 1 SECOND OF PERIODONTAL AIR POLISHING. THE PATIENT WAS SENT BY THE DENTIST TO THE HOSPITAL AFTER HE NOTICED A SWELLING OF THE LEFT SIDE OF FACE, EYE, AND NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403603 HUFRIEDYGROUP DENTAL SCALER AND AIR POLISHER KOJ MECTRON S.P.A. APPAIR 10889950142551

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization