BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE ACTIVA LT MASK MED-AMER

    MDR report key: 1944493 · Received December 23, 2010

    Report

    Report Number
    3004604967-2010-00048
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K032916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESMED MASK IS NOT ALLEGED TO BE THE CAUSE OF THE ALLERGIC REACTION; HOWEVER, THE DME AND PT ARE UNABLE TO DETERMINE ANY CHANGES TO THE PT'S LIFESTYLE THAT MAY HAVE CAUSED THE REACTION. THE DEVICE HAS NOT BEEN RETURNED FOR AN EVALUATION. RESMED HAS REQUESTED THE MASK BE RETURNED SO THEN AN ENGINEERING EVAL COULD BE PERFORMED. THERE WAS NO REPORT OF PERMANENT INJURY RELATING TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT HAD AN ALLERGIC REACTION POSSIBLY RELATED TO WEARING THEIR CPAP MASK. THE ALLERGIC REACTION REQUIRED THEM TO VISIT THE HOSPITAL ER WHERE THEY RECEIVED AN EPINEPHRINE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE ACTIVA LT MASK MED-AMER BZD RESMED LTD. 60148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other