BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMA ELITE

    MDR report key: 17600813 · Received August 23, 2023

    Report

    Report Number
    3011300255-2023-00004
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    January 26, 2023
    Report Date
    August 22, 2023
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EFB
    UDI-DI
    00304040153857
    PMA / PMN Number
    K162926
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED REPORT NUMBER: (B)(4). THE COMPLAINED CONTRA-ANGLE HANDPIECE WAS EXAMINED BY W&H AND NO TECHNICAL FAULT ON THE PART OF W&H COULD BE DETECTED. THUS, THE INITIAL ASSESSMENT (LACK OF MAINTENANCE) OF THE DISTRIBUTOR AS THE CAUSE OF THE STRONG HEATING CAN BE CONFIRMED AS PLAUSIBLE.

    Description of Event or Problem · 0

    AFTER SEVERAL USES, THE PRODUCT HEATED UP AND BURNED THREE (3) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264645 MAXIMA ELITE HANDPIECE EFB W&H DENTALWERK BUERMOOS GMBH MAXIMA ELITE 2 1:5 00304040153857

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other