BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIO CS DESENSITIZER

    MDR report key: 4237297 · Received October 24, 2014

    Report

    Report Number
    9612352-2014-00002
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    August 17, 2014
    Report Date
    September 5, 2014
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EMA
    PMA / PMN Number
    K003407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TELIO CS DESENSITIZER IS USED TO CLOSE DENTINE TUBULI AND FOR EXAMPLE TO TREAT SENSITIVE TOOTH NECKS. IN THIS PARTICULAR CASE THE PT WAS AWARE OF NUMBNESS DURING THE TREATMENT. THE SYMPTOMS WERE DESCRIBED BY THE PT. THEY COULD INDICATE AN ALLERGIC REACTION. PRODUCTION RECORDS FOR THIS BATCH WERE NORMAL.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT FROM THE DENTIST THE PT COMPLAINED OF UNPLEASANT NUMBNESS DIRECTLY AFTER THE PROPHYLAXIS TREATMENT. AFTER TWO DAYS THE PT CONTACTED THE DENTISTS AGAIN AND REQUESTED AN APPOINTMENT BECAUSE THE GINGIVA WAS DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677777 TELIO CS DESENSITIZER DENTAL MATERIAL, DESENSITIZING RESIN EMA IVOCLAR VIVADENT AG T10346

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention