BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPHY-JET POWDER

    MDR report key: 858280 · Received June 1, 2007

    Report

    Report Number
    2424472-2007-00127
    Event Type
    Injury
    Date Received
    June 1, 2007
    Report Date
    May 3, 2007
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    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 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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. FURTHER INFORMATION PERTAINING TO THIS EVENT, INCLUDING EVALUATION RESULTS WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED SWELLING, PAIN, AND PEELING OF THE ORAL MUCOSA AFTER A PROCEDURE WAS PERFORMED USING PROPHY-JET POWDER. THE PATIENT CONSULTED A PHYSICIAN AND WAS ADMINISTERED HOMEOPATHIC SODIUM CHLORIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPHY-JET POWDER EJR DENTSPLY PROFESSIONAL NA 06041

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other VASELINE