BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA MIRAGE II MASK SYS STD-USA

    MDR report key: 1575115 · Received January 7, 2010

    Report

    Report Number
    3004604967-2010-00001
    Event Type
    Injury
    Date Received
    January 7, 2010
    Date of Event
    December 8, 2009
    Report Date
    January 7, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K050359
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED TO RESMED FOR EVAL. BASED ON CLINICAL OPINION PROVIDED BY RESMED'S MEDICAL DIRECTOR, THE PROBABLE CAUSE IS THE HEADGEAR DISRUPTED THE SCALP EPITHELIUM CAUSING A SUPERFICIAL ULCER WHICH SUBSEQUENTLY BECAME INFECTED WITH A BACTERIA, IN THIS CASE.

    Description of Event or Problem · 1

    A PT USING A RESMED CPAP MASK REPORTED, THEY ACQUIRED A MRSA INFECTION BY WEARING THEIR MASK HEADGEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA MIRAGE II MASK SYS STD-USA ULTRA MIRAGE II BZD RESMED LTD. 16548 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1