BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 3802729 · Received May 9, 2014

    Report

    Report Number
    2016150-2014-00101
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SYBRONENDO
    Product Code
    KIF
    PMA / PMN Number
    K102163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. THE DOCTOR REPORTED THAT MULTIPLE PATIENTS HAD RETURNED ANYWHERE FROM SIX (6) MONTHS TO TWO (2) YEARS AFTER THE INITIAL ROOT CANAL PROCEDURE HAD BEEN COMPLETED DUE TO FAILURE OF THE REALSEAL TREATMENT. THE DOCTOR RETREATED THE ROOT CANALS AND PRESCRIBED ANTIBIOTICS AND/OR PAINKILLERS FOR TREATMENT. OVER-THE-COUNTER TREATMENTS SUCH AS IBUPROFEN OR TYLENOL WERE ALSO RECOMMENDED. TO DATE, EACH OF THE PATIENTS HAVE FULLY RECOVERED AND ARE DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER OR CATALOG NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE REALSEAL TREATMENT IN ROOT CANALS FOR MULTIPLE PATIENTS HAD FAILED AND THE PATIENTS HAD EXPERIENCED GENERAL MALAISE, INFECTIONS, AND REQUIRED ROOT CANAL RETREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280554 REALSEAL RESIN, ROOT CANAL FILLING KIF SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R