BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGE MICRO MASK MED&LG-AMERICA

    MDR report key: 1221821 · Received November 4, 2008

    Report

    Report Number
    3004604967-2008-00016
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 31, 2008
    Product Code
    BYG
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASK HAS NOT BEEN EVALUATED BY RESMED CORP. RESMED HAS REQUESTED THE MASK INVOLVED IN THE INCIDENT BE RETURNED TO MANUFACTURER SO THAT FURTHER EVAL COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE PT HAD AN ALLERGIC REACTION TO A RESMED MASK THAT CREATED BLISTERS (POSSIBLE SCARRING) ON THE SIDE OF HER NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE MICRO MASK MED&LG-AMERICA MIRAGE MICRO MASK MED&LG-AMERICA BYG 16334 199270

    Patients

    Seq Age Sex Outcome Treatment
    1