BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPBOND CLEAR WITH TRICLOSAN

    MDR report key: 2042772 · Received April 6, 2011

    Report

    Report Number
    2024312-2011-00070
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 17, 2011
    Manufacturer
    KERR COPORATION
    Product Code
    EMA
    PMA / PMN Number
    K053565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR ALLEGED THAT ENDODONTIC TREATMENT WAS PERFORMED ON THE PATIENT IN ORDER TO DEVITALIZE THE TOOTH THAT WAS TREATED WITH TEMPBOND CLEAR WITH TRICLOSAN. THE DOCTOR STATED THAT HE THINKS THAT THE PRODUCT MAY HAVE DAMAGED THE PULP OF THESE TEETH; HOWEVER, BECAUSE THE DOCTOR DID NOT RESPOND TO FURTHER REQUESTS FOR ADDITIONAL INFORMATION, THIS ALLEGATION COULD NOT BE CONFIRMED. NO PRODUCT WAS RETURNED AND THE DOCTOR WAS UNABLE TO IDENTIFY THE LOT NUMBER THAT WAS USED IN THE INCIDENT. THEREFORE, NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A DOCTOR ALLEGED THAT TEN (10) PATIENTS REQUIRED ENDODONTIC TREATMENT IN ORDER TO DEVITALIZE TEETH THAT THE DOCTOR BELIEVES MAY HAVE BEEN DAMAGED BY TEMPBOND CLEAR WITH TRICLOSAN. THIS MDR IS THE SIXTH OF TEN REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPBOND CLEAR WITH TRICLOSAN CEMENT, DENTAL EMA KERR COPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention