BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGE 1 FULL FACE MASK - LARGE

    MDR report key: 514326 · Received January 14, 2004

    Report

    Report Number
    8020057-2004-00001
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    December 5, 2003
    Report Date
    January 14, 2004
    Manufacturer
    RESMED LTD.
    Product Code
    BYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT HAD AN ALLERGIC REACTION THAT WAS LIFE THREATENING WHEN USING A RESMED FULL FACE MIRAGE 1 LARGE MASK. PT WENT TO AN URGENT CARE CENTER FOR TREATMENT ACCORDING TO THE REPORTING RESPRIRATORY THERAPIST. THE REACTION INVOLVED RASH AND SWELLING OF THE HEAD, TONGUE AND FACE. AS OF 12/2003 PT HAS BEEN FITTED WITH A COMPETITOR'S MASK AND IS DOING FINE PER THEIR THERAPIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE 1 FULL FACE MASK - LARGE FULL FACE MASK FOR CPAP DEVICE BYG RESMED LTD. 16630 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening