BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTSPLY SIRONA DENTAL ELECTRIC HANDPIECE

    MDR report key: 24377804 · Received February 18, 2026

    Report

    Report Number
    MW5184000
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    February 11, 2026
    Report Date
    February 12, 2026
    Manufacturer
    DENTSPLY SIRONA INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BACK OF HEAD OF ELECTRIC HANDPIECE OVERHEATED DURING USE, CAUSING LIP BURN DURING DENTAL TREATMENT. DENTSPLY SIRONA BRAND HANDPIECE, MODEL: MIDWEST E+ATT1.5L, SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445350 DENTSPLY SIRONA DENTAL ELECTRIC HANDPIECE HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY SIRONA INC. MIDWEST E+ ATT 1.5L

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Other