BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPHY-JET POWDER

    MDR report key: 1923582 · Received December 8, 2010

    Report

    Report Number
    2424472-2010-00120
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    November 10, 2010
    Manufacturer
    DENTSPLY DETREY
    Product Code
    KOJ
    PMA / PMN Number
    K970342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE PROPHY-JET POWDER USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS OT 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 IS WAS REPORTED THAT FIVE DIFFERENT PATIENTS EXPERIENCED LIP SWELLING AND ABLATION OF THE ORAL MUCOSA AFTER A PROCEDURE WAS PERFORMED USING PROPHY-JET POWDER. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. LATEX GLOVES WERE USED BY THE DENTAL PROFESSIONAL IN THESE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPHY-JET POWDER KOJ DENTSPLY DETREY 091118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other