BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPHY-JET POWDER

    MDR report key: 2032263 · Received March 23, 2011

    Report

    Report Number
    2424472-2011-00001
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    February 25, 2011
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K970342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 LIP SWELLING AND REDNESS DURING A PROCEDURE THAT WAS PERFORMED USING PROPHY-JET POWDER. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. LATEX GLOVES WERE USED BY THE CLINICIAN DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPHY-JET POWDER KOJ DENTSPLY PROFESSIONAL 100331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CHERRY FLAVORED BLISTEX