BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGE QUATTRO FFM SYS-LGE AMERICAS

    MDR report key: 1054732 · Received May 29, 2008

    Report

    Report Number
    3004604967-2008-00006
    Event Type
    Other
    Date Received
    May 29, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 13, 2008
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MASK WAS EVALUATED BY RESMED CORP. AND NO PROBLEMS WERE IDENTIFIED. MASK WAS SENT TO RESMED DESIGN AND MANUFACTURING FACILITY FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    ON MAY 2, 2008 RESMED RECEIVED A COMPLAINT VIA OUR WEBSITE AND THE PT CLAIMED THAT OUR QUATTRO MASK LEFT A DEEP WOUND ON THE BRIDGE OF HIS NOSE. PT ALSO PROVIDED PICTURES OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE QUATTRO FFM SYS-LGE AMERICAS MIRAGE QUATTRO FFM BZD RESMED LTD. 61203 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1