BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIO CS DESENSITIZER

    MDR report key: 4237319 · Received September 5, 2014

    Report

    Report Number
    9612352-2014-00015
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 17, 2014
    Report Date
    September 5, 2014
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EMA
    PMA / PMN Number
    K003407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LS
    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 DENTIST AGAIN AND REQUESTED AN APPOINTMENT BECAUSE THE GINGIVA WAS DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543196 TELIO CS DESENSITIZER DENTAL MATERIAL, DESENSITIZING RESIN EMA IVOCLAR VIVADENT AG T10346

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention