BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA MIRAGE MASK

    MDR report key: 1009720 · Received March 6, 2008

    Report

    Report Number
    3004604967-2008-00002
    Event Type
    Other
    Date Received
    March 6, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 29, 2008
    Manufacturer
    RESMED LTD.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DID NOT RETURN THE MASK TO US FOR INSPECTION, AND HE ALSO DID NOT CLARIFY WHAT SIZE OF MASK THAT HE WAS USING WHEN THE PROBLEM OCCURRED. PATIENT HAS NOT YET PROVIDED ANY MEDICAL RECORDS AS REQUESTED BY RESMED.

    Description of Event or Problem · 1

    PATIENT SENT A LETTER TO OUR CEO AND STATED THAT OUR ULTRA MIRAGE MASK CAUSED AN INFECTION IN THE UPPER JAW AREA BETWEEN THE NOSE AND MOUTH. THE LETTER FURTHER STATES THAT THE MASK MAY HAVE CAUSED THE INFECTION AND MAY HAVE CAUSED SOME DENTAL PROBLEMS BY PUTTING PRESSURE ON HIS UPPER TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA MIRAGE MASK ULTRA MIRAGE MARK BYG RESMED LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1