BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JET FRESH

    MDR report key: 1739627 · Received June 25, 2010

    Report

    Report Number
    2424472-2010-00096
    Event Type
    Injury
    Date Received
    June 25, 2010
    Report Date
    May 27, 2010
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K014188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH THE SYMPTOMS OF AN ACUTE ALLERGIC REACTION ARE TYPICALLY DERMATOLOGICAL IN NATURE AND THE SYMPTOMS REPORTED IN THIS CASE ARE NOT CONSISTENT WITH PREVIOUSLY REPORTED ALLERGIC REACTION EVENTS INVOLVING SIMILAR PRODUCTS, THE POSSIBILITY THAT AN ALLERGIC REACTION OCCURRED CANNOT BE EXCLUDED. WHILE IT IS UNK IF THE JET FRESH PROPHY POWDER USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'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 CFR 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 WITHIN AN HOUR OF A PROCEDURE PERFORMED USING JET FRESH PROPHY POWDER, THE PT'S FACE BECAME FLUSHED AND THE PT BECAME THIRSTY. WITHIN TWO HOURS, THE PT REPORTED DEVELOPING STOMACH CRAMPS AND CHILLS; BLOOD PRESSURE AND HEART RATE BECAME RAISED. THAT EVENING THE PT REPORTED HAVING DIARRHEA. TWENTY FOUR HOURS FOLLOWING THE PROCEDURE, THE PT REPORTED THAT THE SYMPTOMS HAD RESOLVED, THOUGH HEART RATE WAS HIGH FOR TWO ADDITIONAL DAYS. NO INTERVENTION WAS REQUIRED TO TREAT THE SYMPTOMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other