BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPBOND CLEAR

    MDR report key: 3063450 · Received April 17, 2013

    Report

    Report Number
    2024312-2013-00162
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K053565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE, GENDER, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT IN ORDER TO OBTAIN FURTHER PATIENT AND INCIDENT DETAILS; HOWEVER, THE COMPLAINANT HAS REMAINED UNRESPONSIVE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT HE ONLY EXPERIENCED THE BLACK STAINING WHEN HE USED THE VISCOSTAT 22% FERRIC SULFATE PRODUCT BEFORE SEATING TEMPORARY RESTORATIONS WITH THE TEMPBOND CLEAR PRODUCT. THE VISCOSTAT INSTRUCTIONS FOR USE STATE: "WHEN THE TOOTH IS NOT THOROUGHLY CLEANED, RESIDUAL HEMOSTATIC AGENT OR CAGULUM LEFT ON THE TOOTH SURFACE OR SURROUNDING TISSUE MAY CONTAMINATE DENTIN AND/OR ENAMEL SUBSTRATE JEAPORDIZING THE BOND AND SEAL CAUSING MICROLEAKAGE. HEMOSIDERIN FROM RESIDUAL BLOOD IN THE SULCUS OR IN THE COAGULUM CAN MOVE BETWEEN THE RESTORATION AND TOOTH PRODUCING A DARK STAIN ON THE UNDERLYING PREPARATION. THIS MAY OCCUR WITHIN DAYS OR WEEKS OF PLACING RESTORATIONS AND WILL REQUIRE RE-TREATMENT AND REPLACEMENTS. THESE INVESTIGATION RESULTS INDICATE THAT THIS INCIDENT OCCURRED AS A RESULT OF A USER/TECHNIQUE RELATED ISSUE AND WAS NOT DUE TO A PRODUCT FAILURE.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT SEVERAL PATIENTS HAD EXPERIENCED TOOTH DISCOLORATION AFTER THE REMOVAL OF TEMPORARY RESTORATIONS WHICH HAD BEEN PLACED USING TEMPBOND CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166391 TEMPBOND CLEAR CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R EPINEPHRINE| VISCOSTAT