BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR-FLOW POWDER PERIO

    MDR report key: 2851118 · Received November 16, 2012

    Report

    Report Number
    3004096429-2012-00004
    Event Type
    Other
    Date Received
    November 16, 2012
    Report Date
    November 14, 2012
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS SA
    Product Code
    EFB
    PMA / PMN Number
    082791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RISK OF ALLERGY HAS BEEN IDENTIFIED IN THE RISK ANALYSIS OF THE PERIO POWDER AND MENTIONED IN THE GENERAL INSTRUCTIONS OF THE POWDER AND IN THE INSTRUCTIONS FOR USE OF THE HANDY PERIO HAND-PIECE. HOWEVER THE DENTIST REPORTS THIS CASE MAY BE DIAGNOSED AS A QUINCKE OEDEME. CURRENTLY AND WITHOUT THE MEDICAL REPORT, WE DO NOT HAVE THE CONFIRMATION OF SUCH DIAGNOSIS. MEDICAL REPORT HAS BEEN REQUESTED FOR MORE INVESTIGATIONS. BATCH HAS BEEN CHECKED AND NO OBSERVATIONS NEITHER DEVIATION OBSERVED ON THE MANUFACTURING AND SPECIFICATION SIDE. ALLERGY IS ALREADY A POSSIBLE REACTION DESCRIBED AS PART OF (B)(4) FOR THIS PERIO POWDER.

    Description of Event or Problem · 1

    PATIENT HAD AN ALLERGIC REACTION, WHICH DEVELOPED WITHIN APPROXIMATELY 1 MINUTE AFTER HER MUCOSA/TEETH WERE EXPOSED TO THE AIR-FLOW PERIO POWDER. SYMPTOM HAS BEEN DESCRIBED AS QUINCKE CEDEME AND WAS TREATED IN ACCORDANCE WITH CLINICAL GUIDELINES THEN THE ALLERGIC REACTION SUBSIDED SWIFTLY. THE DETAILED MEDICAL REPORT IS TO BE SENT BY DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR-FLOW POWDER PERIO DENTAL ABRASIVE MATERIAL, POWDER EFB E.M.S. ELECTRO MEDICAL SYSTEMS SA DV-070 1105241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other