BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWR PAIR

    MDR report key: 24584082 · Received March 12, 2026

    Report

    Report Number
    1416605-2026-00002
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 12, 2026
    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
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE MAY BE CROSSED AIR AND WATER LINES BASED ON THE DESCRIPTION OF THE ISSUE. THIS WILL CAUSE A CLOG IN THE UNIT AND LACK OF AIR AND / OR WATER IN THE LINE BASED ON HISTORICAL RETURNS. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    DENTIST REPORTED WHILE USING THE PWR AIR POLISHER IT WAS DAMAGING THE TISSUE ON GUMS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579107 PWR PAIR AIRBRUSH KOJ HU-FRIEDY MFG. CO. LLC APPAIR 10889950142551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other