BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE QUATTRO FFM SYS XSML-AMER

    MDR report key: 1624456 · Received March 5, 2010

    Report

    Report Number
    3004604967-2010-00014
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 5, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K063122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASK WAS NOT RETURNED TO RESMED FOR EVAL. BASED ON INFO AVAILABLE, RESMED IS UNABLE TO CONFIRM THE ROOT CAUSE OF THE COMPLAINT.

    Description of Event or Problem · 1

    ON FEBRUARY 5, 2010, RESMED RECEIVED A COMPLAINT FROM A PT CLAIMING A CPAP MASK LEFT A SCAR ON THE RIGHT SIDE OF HER MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE QUATTRO FFM SYS XSML-AMER MIRAGE QUATTRO FFM SYS XSML-AMER BZD RESMED LTD. 61200

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability