BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2983583 · Received February 28, 2013

    Report

    Report Number
    1815757-2013-00001
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EJJ
    PMA / PMN Number
    K820181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT COULD NOT BE RECALLED. THE DOCTOR REPORTED THAT AFTER THE PROCEDURE WAS FINISHED, THE PATIENT HAD REQUESTED VICODIN TO ALLEVIATE SENSITIVITY. THE DOCTOR REFUSED TO GIVE THE PATIENT THE PRESCRIPTION. THE PATIENT THEN ALLEGEDLY LEFT HIS OFFICE AND IMMEDIATELY WENT TO THE ER TO SEEK FURTHER TREATMENT FOR THE SENSITIVITY. THE ER DOCTOR PURPORTEDLY PRESCRIBED THE PATIENT VICODIN FOR TREATMENT. THE DOCTOR STATED THAT AFTERWARDS, THE PATIENT VISITED AT LEAST THREE (3) OTHER DENTISTS WITHIN A 48 HOUR PERIOD OF TIME AND ATTAINED PRESCRIPTIONS FOR VICODIN FROM EACH ONE. THE LAST DENTIST THE PATIENT HAD VISITED ALLEGED THAT THE ALL OF THE CONTOUR RESTORATIONS WERE TARNISHED AND CAUSING SENSITIVITY BECAUSE THEY HAD NOT BEEN PROPERLY CONDENSED. THIS DENTIST REPLACED ALL TWELVE (12) RESTORATIONS APPROXIMATELY TWO (2) WEEKS AFTER THE INITIAL PLACEMENT OF THE ALLOY. NO FURTHER INFORMATION WITH REGARD TO THE PATIENT COULD BE PROVIDED BY THE DOCTOR AS HE HAD NOT SEEN HER SINCE THAT INITIAL VISIT.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT IMMEDIATELY AFTER HAVING PLACED TWELVE (12) CONTOUR ALLOY RESTORATIONS FOR A PATIENT, THE PATIENT ALLEGED EXPERIENCING SENSITIVITY. THE PATIENT ALSO ALLEGED AT A LATER DATE THAT ALL TWELVE (12) RESTORATIONS HAD TARNISHED WITHIN TWO (2) WEEKS OF PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87073 CONTOUR DENTAL AMALGAM, MERCURY, AND AMALGAM ALLOY EJJ KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R