BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPBOND CLEAR WITH TRICLOSAN

    MDR report key: 3011728 · Received March 19, 2013

    Report

    Report Number
    2024312-2013-00089
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K053565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WERE NOT PROVIDED. A PERMANENT CROWN WAS PLACED FOR THE PATIENT FOLLOWING THE REMOVAL OF THE TEMPORARY RESTORATION, WITHOUT FURTHER INCIDENT. THE PRODUCT WAS NOT RETURNED; THEREFORE, A PHYSICAL TEST WAS PERFORMED ON RETAINED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Additional Manufacturer Narrative · 1

    A CORRECTION WAS MADE TO THE LOT # IN THIS REPORT. THE LOT NUMBER WAS UPDATED TO THE CORRECT LOT NUMBER OF 4610120. ADDITIONAL INFORMATION REGARDING THE EVALUATION OF RETURNED PRODUCT WAS UPDATED IN THIS REPORT. A PHYSICAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT TEMPORARY RESTORATIONS PLACED WITH TEMPBOND CLEAR HAD TO BE CUT OFF DURING PROCEDURES FOR APPROXIMATELY SEVEN (7) PATIENTS. THIS IS THE FIRST OF SEVEN (7) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114704 TEMPBOND CLEAR WITH TRICLOSAN CEMENT, DENTAL EMA KERR CORPORATION 4610120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R