BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBRONENDO

    MDR report key: 8197500 · Received December 26, 2018

    Report

    Report Number
    2016150-2018-00064
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    November 27, 2018
    Report Date
    December 26, 2018
    Manufacturer
    SYBRONENDO
    Product Code
    EKZ
    PMA / PMN Number
    K031664
    Removal / Correction Number
    Z-0413-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO ETHNICITY, AND RACE. THE PRODUCT HAS BEEN IDENTIFIED AS A POTENTIAL AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.

    Description of Event or Problem · 1

    A COMPLAINANT ALLEGED THE UNIT IS OVERHEATING AND ASSISTANT BURNED THEIR FINGER. THE ASSISTANT DID NOT REQUIRE A VISIT TO A PHYSICIAN OFFICE. IT WAS REPORTED THAT THE ASSISTANT HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035016 SYBRONENDO ELEMENTS OBTURATION UNIT EKZ SYBRONENDO 91-25387

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR