BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAKE 1 ADVANCED

    MDR report key: 1961743 · Received January 14, 2011

    Report

    Report Number
    1815757-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    Manufacturer
    KERR CORPORATION
    Product Code
    ELW
    PMA / PMN Number
    K092176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR DID NOT DISCLOSE THE DATES OR DETAILS OF THE INCIDENTS, NOR DID HE DISCLOSE THE NUMBER OF AFFECTED PATIENTS, BUT IT WAS CONFIRMED THAT ALL THE AFFECTED PATIENTS ARE DOING FINE. THE PRODUCT WAS RETURNED TO KERR CORPORATION FOR EVALUATION AND ALTHOUGH THE ALLEGED PRODUCT PROBLEM COULD NOT BE REPRODUCED, THE RETURNED MATERIAL MET PRODUCT SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT ALSO MET ALL RELEASE SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED IN REGARDS TO THIS PRODUCT LOT. THESE INVESTIGATION RESULTS INDICATE THAT THIS INCIDENT WAS NOT A RESULT OF A PRODUCT FAILURE AND THAT IT WAS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6), 2010, KERR CORPORATION RECEIVED NOTIFICATION FROM A DOCTOR THAT THE USE OF TAKE 1 ADVANCED RESULTED IN POOR IMPRESSIONS AND SUBSEQUENT POORLY FITTING CROWNS AND BRIDGES, MAKING IT NECESSARY FOR PATIENTS TO RETURN TO HIS OFFICE AND HAVE NEW IMPRESSIONS AND RESTORATIONS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAKE 1 ADVANCED IMPRESSION MATERIAL ELW KERR CORPORATION 0-1131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other