BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPHY-JET POWDER

    MDR report key: 1561896 · Received December 10, 2009

    Report

    Report Number
    2424472-2009-00196
    Event Type
    Injury
    Date Received
    December 10, 2009
    Report Date
    November 11, 2009
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K970342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE POWDER USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OFFICE WORKER DEVELOPED A RASH ON MULTIPLE OCCASIONS FOLLOWING THE USE OF PROPHY-JET POWDER BY ANOTHER STAFF MEMBER IN A DIFFERENT ROOM. THE AFFECTED INDIVIDUAL CONSULTED AN ALLERGIST, THOUGH IT IS UNK WHETHER ANY INTERVENTION WAS REQUIRED AND RESULTS OF ANY TESTING PERFORMED ARE NOT AVAILABLE AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPHY-JET POWDER KOJ DENTSPLY PROFESSIONAL NA 090526

    Patients

    Seq Age Sex Outcome Treatment
    1 Other