BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA MIRAGE FULL FACE MASK SYSTEM

    MDR report key: 966122 · Received December 14, 2007

    Report

    Report Number
    3004604967-2007-00008
    Event Type
    Other
    Date Received
    December 14, 2007
    Date of Event
    October 2, 2007
    Report Date
    November 20, 2007
    Manufacturer
    RESMED LTD.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT TOLD THE DME ABOUT HIS SYMPTOM AND SHE INFORMED RESMED BUT NOBODY SAW OR HAD ANY PICTURES RELATED TO HIS CONDITION AND THE MASK WAS DISCARDED. WHEN CONTACTED BY RESMED, PT COULD NOT CONFIRM WHAT TYPE OF MASK HE HAD, NOR COULD, OR DID HE PROVIDE ANY ADDITIONAL INFO.

    Description of Event or Problem · 1

    REP INFORMED OUR RESMED PT ADVOCATE THAT THE PT CLAIMED THAT THE MASK HE WAS USING, LEFT A PERMANENT SCAR ON HIS FACE AND THAT IT HAS CAUSED HIM TO DEVELOP BACTERIAL CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA MIRAGE FULL FACE MASK SYSTEM ULTRA MIRAGE FULL FACE MASK BYG RESMED LTD. 60602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR