BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JET FRESH PROPHY POWDER

    MDR report key: 485761 · Received September 27, 2003

    Report

    Report Number
    2424472-2003-00148
    Event Type
    Injury
    Date Received
    September 27, 2003
    Date of Event
    August 29, 2003
    Report Date
    August 29, 2003
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED SWELLING ON ONE SIDE OF THE FACE AND NUMBNESS OF THE MOUTH, AFTER AN AIR POLISHING PROCEDURE. THE PATIENT WAS GIVEN BENADRYL TO REDUCE THE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JET FRESH PROPHY POWDER CLEANING POWDER EJR DENTSPLY PROFESSIONAL NA 030121

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention