BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGE LIBERTY FM SYS SML-AMER

    MDR report key: 2893286 · Received December 21, 2012

    Report

    Report Number
    3004604967-2012-00056
    Event Type
    Other
    Date Received
    December 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 20, 2012
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K063011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED THE MASK BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. BASED ON THE INTERVIEW BETWEEN RESMED AND THE PATIENT, THE PATIENT STATED THAT SHE DEVELOPED A SMALL SORE ON HER CHEEK WHERE THE PLASTIC CLIPS OF THE HEADGEAR CONTACT HER FACE. THE SORE BECAME PAINFUL CAUSING HER TO SEEK MEDICAL ATTENTION. THE PATIENT THEN STATED THAT HER DOCTOR SURGICALLY REMOVED THE SORE FROM HER CHEEK. THE PATIENT STATED THAT HER CHEEK HEALED AFTER SURGERY AND CURRENTLY DOES NOT WANT TO WEAR A MASK THAT MIGHT TOUCH THE AREA ON HER FACE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A MIRAGE LIBERTY MASK SYSTEM CAUSED A SORE ON THE PATIENT'S RIGHT CHEEK WHICH REQUIRED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE LIBERTY FM SYS SML-AMER BZD RESMED LTD. 61300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other