BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JET-FRESH PROPHY POWDER

    MDR report key: 2818356 · Received October 24, 2012

    Report

    Report Number
    2424472-2012-00001
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 28, 2012
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K014188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE 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, THIS EVENT IS MORE LIKELY THE RESULT OF THE MATERIAL INADVERTENTLY BEING DIRECTED INTO THE SOFT TISSUE, NOT AN ALLERGIC RESPONSE. AS SUCH, THE ADMINISTRATION OF PREDNISONE IS UNLIKELY TO HAVE BEEN REQUIRED TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE AND IS NOT LIKELY ATTRIBUTED TO RESOLUTION OF THE SYMPTOMS. HOWEVER, SINCE ADMINISTRATION OF PREDNISONE IS CONSIDERED MEDICAL INTERVENTION, REGARDLESS OF WHETHER IT WAS THE APPROPRIATE TREATMENT OR NOT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED BY A DOCTOR THAT WHEN HE USED MINT JET-FRESH POWDER ON A PT, SHE STARTED COMPLAINING ABOUT PAIN AND SWELLING. THE DOCTOR STATED THAT HE SENT THE PT TO EMERGENCY CARE WITHIN THE COMPANY WHERE SHE WAS GIVEN PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JET-FRESH PROPHY POWDER KOJ DENTSPLY PROFESSIONAL 1202071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DISCLOSING SOLUTION