BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTAPER UNIVERSAL OBTURATORS

    MDR report key: 1131914 · Received August 20, 2008

    Report

    Report Number
    2320721-2008-00077
    Event Type
    Injury
    Date Received
    August 20, 2008
    Report Date
    July 21, 2008
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING AND DIFFICULTY BREATHING A FEW HOURS AFTER PLACEMENT OF THERMAFIL OBTURATORS. THE PATIENT WENT TO THE EMERGENCY ROOM AS A RESULT AND WAS ADMINISTERED AN ANTIHISTAMINE AND A STEROID. A FEW HOURS AFTER THE PRESCRIPTION WAS EXHAUSTED, THE PATIENT REPORTED THAT THE SYMPTOMS RETURNED. A WEEK FOLLOWING PLACEMENT OF THE THERMAFIL, THE TOOTH WAS EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTAPER UNIVERSAL OBTURATORS EKM DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention