BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AH PLUS JET

    MDR report key: 2039188 · Received March 25, 2011

    Report

    Report Number
    8010638-2011-00005
    Event Type
    Injury
    Date Received
    March 25, 2011
    Report Date
    February 18, 2011
    Manufacturer
    DENTSPLY DETREY
    Product Code
    KIF
    PMA / PMN Number
    K960548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    POST-OP SENSITIVITY IS A COMMON OCCURRENCE IN ALL PHASES OF DENTISTRY, IS TYPICALLY REVERSIBLE IN NATURE, AND IN MANY CASES WILL SPONTANEOUSLY RESOLVE. BY DEFINITION AND DISTINCTION FROM ENDODONTIC THERAPY, SENSITIVITY IS NOT IRREVERSIBLE NOR WILL IT BECOME SO IF LEFT UNTREATED. MANY FACTORS CONTRIBUTE TO OCCURRENCE OF SENSITIVITY SUCH THAT NO RELATIONSHIP TO ANY ONE PRODUCT OR STEP OF A PROCEDURE CAN BE ESTABLISHED. THUS, SENSITIVITY IN ITSELF DOES NOT FIT THE DEFINITION OF A SERIOUS INJURY OR A MALFUNCTION. HOWEVER, IN THIS INCIDENT MEDICAL INTERVENTION WAS ADMINISTERED. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE MATERIAL WAS RETURNED, EVALUATED AND FOUND TO BE WITHIN SPEC.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT SEVERAL PTS EXPERIENCED POST OPERATIVE SENSITIVITY AFTER USE OF AH PLUS JET; ANTIBIOTICS WERE ADMINISTERED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AH PLUS JET KIF DENTSPLY DETREY 1006001831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention