BEUDAMED
    FDA Adverse Event Injury Summary report: N

    W&H

    MDR report key: 22164394 · Received June 8, 2025

    Report

    Report Number
    3003755849-2025-00004
    Event Type
    Injury
    Date Received
    June 8, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 3, 2025
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    KMW
    PMA / PMN Number
    K080939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE ANALYSIS, IT WAS FOUND THAT THE HANDPIECE HAD MASSIVE BROWN DEPOSITS AND LIQUID INSIDE. THE UPPER BALL BEARING WAS JAMMED AND RUBBED AGAINST THE BEARING SLEEVE, CAUSING EXCESSIVE HEATING. THE ROOT-CAUSE ANALYSIS REVEALED THAT THE EVENT WAS DUE TO A LACK OF MAINTENANCE.

    Description of Event or Problem · 0

    HANDPIECE OVERHEATING SEVERELY DESPITE IRRIGATION. SEVERE BURN OF THE PATIENT LIP DUE TO OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551122 W&H SURGICAL HANDPIECEE KMW W&H DENTALWERK BUERMOOS GMBH S-11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other