BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO AIR FFM MED-AMER

    MDR report key: 6691050 · Received July 6, 2017

    Report

    Report Number
    3004604967-2017-00921
    Event Type
    Injury
    Date Received
    July 6, 2017
    Report Date
    July 6, 2017
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K123979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE REPORTER, DURING A RECENT DATA COLLECTION STUDY CONDUCTED IN THE US IN EARLY (B)(6), THEY MET A PATIENT USING A QUATTRO AIR MASK SYSTEM WHO COMPLAINED ABOUT THE HEADGEAR RUBBING AND THOUGHT IT MIGHT HAVE CAUSED A CYST ON HIS HEAD WHICH HE HAD TO GET SURGICALLY REMOVED. THE MASK WAS NOT RETURNED TO RESMED FOR EVALUATION. RESMED HAS REQUESTED ADDITIONAL INFORMATION FROM THE REPORTER AND THE REPORTER STATED THAT AT THIS STAGE THERE IS NO FURTHER INFORMATION AVAILABLE. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A QUATTRO AIR FULL FACE MASK SYSTEM ALLEGEDLY CAUSED CYST FORMATION ON A PATIENT AND THE PATIENT SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472025 QUATTRO AIR FFM MED-AMER BZD RESMED LTD 62702

    Patients

    Seq Age Sex Outcome Treatment
    1