BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 7927963 · Received October 2, 2018

    Report

    Report Number
    2016150-2018-00054
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    October 2, 2018
    Manufacturer
    SYBRONENDO
    Product Code
    KIF
    PMA / PMN Number
    K102163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARDS TO AGE, GENDER, ETHNICITY, RACE AND WEIGHT WAS NOT PROVIDED. NO LOT NUMBER WAS PROVIDED THEREFORE MANUFACTURE DATE CANNOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT WHILE PERFORMING A RESILON RE-TREATMENT, BLACK PIGMENTATION WAS FOUND IN ALL CANALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769308 REALSEAL RESIN, ROOT CANAL FILLING, KIF SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other