BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR-FLOW PERIO POWDER

    MDR report key: 3199575 · Received June 25, 2013

    Report

    Report Number
    3004096429-2013-00002
    Event Type
    Other
    Date Received
    June 25, 2013
    Report Date
    June 24, 2013
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS SA
    Product Code
    EFB
    PMA / PMN Number
    082791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR MORE INFO ABOUT THE ACCURATE CONDITIONS OF THE OEDEME'S APPEARANCE AND THE DATE OF THE EXPIRATIONS OF THE INVOLVED POWER. CURRENTLY WE ARE ABLE TO SAY THAT THE RISK OF ALLERGY HAS BEEN IDENTIFIED IN THE LEAK ANALYSIS OF THE PERIO POWDER AND IN THE INSTRUCTIONS FOR USE OF THE HANDY PERIO HAND-PIECE. ALLERGY IS ALREADY A POSSIBLE REACTION DESCRIBED AS PART OF IFU NUMBER FB-402 FOR THIS PERIO POWDER.

    Description of Event or Problem · 1

    A PT TRIGGERED A QUINCKE OEDEME WITH A PERIO POWDER. ACCORDING THE FIRST INFO, THE APPLIED POWDER WAS OUT OF DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288034 AIR-FLOW PERIO POWDER DENTAL ABRASIVE MATERIAL, POWDER EFB E.M.S. ELECTRO MEDICAL SYSTEMS SA DV-070 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NOT KNOWN YET