BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA MIRAGE II MASK SYS LGE-USA

    MDR report key: 1526137 · Received November 2, 2009

    Report

    Report Number
    3004604967-2009-00024
    Event Type
    Other
    Date Received
    November 2, 2009
    Date of Event
    October 3, 2009
    Report Date
    November 2, 2009
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K050359
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASK WAS NOT RETURNED TO RESMED FOR EVALUATION AND IS NOT ALLEGED TO BE FAULTY. RESMED HAS REQUESTED ALL RELEVANT INFORMATION RELATING TO THE EVENT BE PROVIDED SO THAT FURTHER EVALUATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    PATIENT REPORTED TO RESMED THEY EXPERIENCED TEETH MOVEMENT DUE TO THE USE OF CPAP MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA MIRAGE II MASK SYS LGE-USA ULTRA MIRAGE II BZD RESMED LTD. 16549

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR