BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-12

    MDR report key: 24924982 · Received April 20, 2026

    Report

    Report Number
    3003755849-2026-00001
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 20, 2026
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    KMW
    UDI-DI
    J021300610001
    PMA / PMN Number
    K080939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INSPECTION OF THE AFFECTED HANDPIECE, NO DEFECT/ERROR WAS IDENTIFIED IN THE DEVICE.

    Description of Event or Problem · 0

    THE HANDPIECE WAS USED WITH COPIOUS SALINE IRRIGATION (40%) ATTACHED TO SURGICAL HANDPIECE IRRIGATION INPUT. SIDE OF HANDPIECE (NOT BUR) OVERHEATED AND BURNED PATIENTS'S FACE/LIP DURING DECORONATING CROWN OF TOOTH #18. HANDPIECE OVERHEATED TO HIGH LEVEL CAUSED 2ND DEGREE BURN TO PATIENT ALONG VERMILLION BORDER AND ONTO SKIN OF CHIN. COPIOUS SALINE IRRIGATION WAS UTILIZED/ATTACHED TO HANDPIECE; HOWEVER, OVERHEATING WAS A RESULT OF OVERHEATING/MALFUNCTION OF THE BODY OF THE HAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217226 S-12 SURGICAL HANDPIECE 1:2 KMW W&H DENTALWERK BUERMOOS GMBH 30061000 J021300610001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other