BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JET FRESH

    MDR report key: 1458889 · Received August 26, 2009

    Report

    Report Number
    2424472-2009-00117
    Event Type
    Injury
    Date Received
    August 26, 2009
    Report Date
    July 27, 2009
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    KOJ
    PMA / PMN Number
    K014188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS NO INDICATION THAT THE DEVICE INVOLVED MALFUNCTIONED IN THIS CASE, BECAUSE THE PATIENT WAS PRESCRIBED MEDICATION, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT COMPLAINED OF DIZZINESS AND A SENSATION THAT AIR ENTERED UNDER THE GUMS AFTER JET-FRESH PROPHY POWDER WAS DIRECTED AT AN IMPACTED WISDOM TOOTH DURING A ROUTINE CLEANING PROCEDURE. THE PATIENT WAS IMMEDIATELY TAKEN TO AN URGENT CARE PHYSICIAN WHO NOTED THAT THERE WAS NO SIGN OF AIR EMPHYSEMA AND PRESCRIBED A STEROID. THE TREATING DENTIST ALSO PRESCRIBED AN ANTI-INFLAMMATORY MEDICATION AND AN ANTIBIOTIC AS A PRECAUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention