BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWR PAIR

    MDR report key: 22436418 · Received July 8, 2025

    Report

    Report Number
    1416605-2025-00007
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    May 25, 2025
    Report Date
    November 10, 2025
    Manufacturer
    HU-FRIEDY MFG. CO. LLC
    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

    TECHNICAL EVALUATION SUMMARY: ON SEPTEMBER 19TH 2025, AS SOON AS THE DEVICE WAS RETURNED BY THE CUSTOMER, MECTRON'S TECHNICAL SERVICE LABORATORY CONDUCTED A FULL EVALUATION OF THE PWR PAIR UNIT SERIAL (B)(6) AND ASSOCIATED HANDPIECES. THE FOLLOWING RESULTS WERE OBTAINED: · PWR PAIR ELECTRICAL SAFETY TEST: PASSED SUCCESSFULLY. · PWR AIR PERIO HANDPIECE SERIAL (B)(6): - PRESSURE PROPHY MODE: 3.45 BAR (REFERENCE VALUE: 3.5 BAR +/- 0.1). - PRESSURE PERIO MODE: 2.1 BAR (REFERENCE VALUE: 2.7 BAR +/- 0.1). · PWR PIEZO LED HANDPIECE SERIAL (B)(6): - ARRIVED NON-FUNCTIONAL, SHOWING NO INSERT TUNING AND ZERO INSULATION. EVALUATION: PRESSURE PERIO MODE DEVIATION OF PWR AIR PERIO HANDPIECE IS NOT CONSISTENT WITH THE REPORTED EVENT. IN FACT, THE REDUCED MEASURED PRESSURE, WOULD REDUCE THE RISK OF COMPLICATIONS OF AIR PROPHYLAXIS TREATMENTS. THE SCALER PWR PIEZO LED HANDPIECE CONDITION IS LIKELY DUE TO POST-EVENT USAGE OR DAMAGE DURING TRANSPORT. NO OTHER PROBLEMS OR MULFUNCTIONS WERE DETECTABLE. CLINICAL EVALUATION & CONCLUSION: DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE PATIENT DECLINED TO PROVIDE FURTHER DIAGNOSTIC DETAILS REGARDING THE SUSPECTED AIREMBOLISM. 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.

    Additional Manufacturer Narrative · 0

    DEVICE IS BEING RETURNED TO MANUFACTURER. MANUFACTURER HAS NOT RECEIVED DEVICE AS OF TODAY. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    REPORTED THAT THE PATIENT GOT AIR EMBOLISM DURING AIR POLISHING TREATMENT. PATIENT WAS SENT TO THE HOSPITAL AND STAYED OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157048 PWR PAIR AIR POLISHING KOJ HU-FRIEDY MFG. CO. LLC APPAIR 10889950142551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O