BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPBOND CLEAR

    MDR report key: 2133011 · Received June 17, 2011

    Report

    Report Number
    2024312-2011-00184
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K053565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED SENSITIVITY ON THE TISSUE IMMEDIATELY AFTER PLACEMENT OF THE TEMPORARY RESTORATION WHICH WAS REMOVED AND REPLACED. THE DOCTOR'S OFFICE STATED A DIFFERENT PRODUCT WILL BE USED FOR RECEMENTATION. NO PRESCRIPTION MEDICATION WAS REQUIRED TO TREAT THE PATIENT. NO PRODUCT WAS RETURNED BY THE CUSTOMER. A RETAIN SAMPLE WAS EVALUATED FOR GEL SET TIME AND APPEARANCE AND MET PRODUCT SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO NON-CONFORMANCE OR VARIANCES IN THE MANUFACTURING PROCESS. THESE INVESTIGATION RESULTS INDICATED THAT THIS INCIDENT WAS NOT THE RESULT OF PRODUCT FAILURE. TESTED RETAIN SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A DOCTOR REPORTED THAT TWO (2) PATIENTS EXPERIENCED SENSITIVITY AFTER PLACEMENT OF TEMPORARY RESTORATIONS. THIS MDR IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPBOND CLEAR CEMENT, DENTAL EMA KERR CORPORATION 3381702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other