BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAFIL

    MDR report key: 682313 · Received March 3, 2006

    Report

    Report Number
    2320721-2006-00066
    Event Type
    Injury
    Date Received
    March 3, 2006
    Report Date
    February 3, 2006
    Manufacturer
    DENTSPLY TULSA DENTAL
    Product Code
    EKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AFTER A TOOTH WAS TREATED AND OBTURATED USING THERMAFIL PLUS, IT WAS NOTED THAT INFECTION WAS PRESENT AT THE APEX OF THE TOOTH. ALSO, IT WAS REPROTED THAT A CONTINOUSLY DRAINING FISTULA HAD DEVELOPED. THE PATIENT WAS SUBSEQUENTLY REFERRED TO ANOTHER DOCTOR FOR FURTHER TREATMENT, THOUGH THE DOCTOR HAS REPORTEDLY BEEN UNABLE TO REMOVE THE MATERIAL IN ORDER TO TREAT THE INFECTION. FURTHER INFORMATION WAS REQUESTED, THOUGH NONE IS AVAILABLE AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAFIL GUTTA PERCHA OBTURATOR EKQ DENTSPLY TULSA DENTAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention