BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA MIRAGE HEADGEAR

    MDR report key: 359117 · Received October 25, 2001

    Report

    Report Number
    8020057-2001-00003
    Event Type
    Other
    Date Received
    October 25, 2001
    Date of Event
    October 8, 2001
    Report Date
    October 23, 2001
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED HAD A SEVERE ALLERGIC REACTION FROM THE ULTRA MIRAGE HEADGEAR. ANTIBIOTIC WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47911 ULTRA MIRAGE HEADGEAR HEADGEAR BZD RESMED LTD. 1656H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other