BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPHY-JET POWDER

    MDR report key: 1731344 · Received June 18, 2010

    Report

    Report Number
    2424472-2010-00092
    Event Type
    Injury
    Date Received
    June 18, 2010
    Report Date
    May 21, 2010
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K970342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 IS REPORTABLE PER 21 CRF PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED USING PROPHY-JET POWDER, THE PATIENT FELT SOMETHING ENTER THEIR NOSE AND BEGAN SNEEZING AND PRODUCING MUCOUS; THE PATIENT'S EYES ALSO BECAME SWOLLEN. THE PATIENT TOOK AN ANTIHISTAMINE TO ALLEVIATE THE SYMPTOMS AND REPORTED THAT THE SWELLING RESOLVED WITHIN A FEW DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention