BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2SEAL

    MDR report key: 2032289 · Received March 23, 2011

    Report

    Report Number
    8010638-2011-00004
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    February 21, 2011
    Manufacturer
    DENTSPLY VDW GMBH
    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

    WHILE IT IS UNKNOWN IF THE PROPHY-JET POWDER USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING, PAIN AND A HEADACHE AFTER TREATMENT WITH 2SEAL ROOT CANAL SEALER AND WAS BED RIDDEN FOR TWO DAYS AFTER THE INCIDENT. THERE IS NO INDICATION THAT MEDICAL/SURGICAL INTERVENTION WAS ADMINISTERED. LATEX GLOVES WERE USED BY THE DENTAL PROFESSIONAL IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2SEAL KIF DENTSPLY VDW GMBH 1008000729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other