BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JET FRESH

    MDR report key: 1066588 · Received June 27, 2008

    Report

    Report Number
    2424472-2008-00058
    Event Type
    Injury
    Date Received
    June 27, 2008
    Date of Event
    February 4, 2008
    Report Date
    May 29, 2008
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K014188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SULCUS OR SOFT TISSUE, NOT AN ALLERGIC RESPONSE. AS SUCH, THE ADMINISTRATION OF BENADRYL 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 BENADRYL IS CONSIDERED MEDICAL INTERVENTION, REGARDLESS OF WHETHER IT WAS THE APPROPRIATE TREATMENT OR NOT, THE DEVICE INVOLVED WAS RETURNED, EVALUATED FOR COLOR, APPEARANCE, ODOR, AND PARTICLE SIZE DISTRIBUTION AND FOUND TO BE IN SPECIFICATION. ADDITIONAL LOT NUMBER: 071115.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL PATIENTS DEVELOPED SWELLING OF THE CHEEK AFTER TREATMENT WITH JET-FRESH POWDER. THE PATIENTS WERE ADMINISTERED BENADRYL AS A RESULT AND THE SWELLING REPORTEDLY RESOLVED WITHIN ONE TO TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JET FRESH KOJ DENTSPLY PROFESSIONAL NA 070321

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CAVITRON PROPHY-JET UNIT