BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR-FLOW CLASSIC PROPHYLAXIS POWDER - LEMON

    MDR report key: 965430 · Received December 14, 2007

    Report

    Report Number
    8030987-2007-00002
    Event Type
    Injury
    Date Received
    December 14, 2007
    Date of Event
    October 23, 2007
    Report Date
    November 30, 2007
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Product Code
    EJR
    PMA / PMN Number
    K900709A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EMS RISK ASSESSMENT IDENTIFIES THE PROBABILITY OF ALLERGIC REACTIONS INCLUDING ANAPHYLACTIC SHOCK TO THE AIR-FLOW LEMON POWDER: SEVERITY: CRITICAL (DEATH AND SERIOUS INJURY IMPROBABLE). FINAL RISK CLASS: TOLERABLE. THE RISK OF ALLERGY IS FORESEEABLE AND CLINICALLY ACCEPTABLE IN VIEW OF THE INDIVIDUAL PT BENEFIT, HAVING A CERTAIN FUNCTIONAL OR NUMERICAL PREDICTABILITY. THE INSTRUCTIONS FOR USE (MANUFACTURER'S LABELING) MAKE THE USER AWARE OF THE RISK OF ALLERGIC REACTIONS: "THE FLAVOUR CONTAINED IN THE POWDER CAN LEAD, IN SPECIFIC CASES, TO ALLERGIC REACTIONS. FOR PTS KNOWN TO SUFFER FROM SUCH REACTIONS, USE THE "NEUTRAL" POWDER PROVIDED BY EMS." [SEE SCANNED PAGES.]

    Description of Event or Problem · 1

    EMS SALES REPRESENTATIVE HAD BEEN INFORMED OCTOBER 23, 2007 OF AN INCIDENT THAT OCCURED AFTER AN AIR POLISHING TREATMENT: ANAPHYLACTIC SHOCK OF THE PT WHO HAD BEEN BROUGHT IMMEDIATELY TO THE HOSPITAL. THE PT RECOVERED AFTER CORTISONE TREATMENT. BASED ON THE INFORMATION PROVIDED, THERE HAS BEEN NO REPORTED INDICATION OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR-FLOW CLASSIC PROPHYLAXIS POWDER - LEMON AIR POLISHING POWDER (FOR AIR POLISHER) EJR E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization