BEUDAMED
    FDA Adverse Event Summary report: N

    AM3

    MDR report key: 2536589 · Received April 10, 2012

    Report

    Report Number
    MW5025017
    Date Received
    April 10, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 10, 2012
    Manufacturer
    ERT
    Product Code
    BZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUBJECT STARTED STUDY USING AM3 DEVICE EVENING OF (B)(6) 2012 AND CONTINUED THRU THE MORNING OF (B)(6) 2012. SUBJECT RETURNED DEVICE ON (B)(6) 2012 STATING BLOWING INTO DEVICE TWICE A DAY MADE HER CHEST TIGHTEN UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AM3 AM3 BZG ERT 96127456

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR PROAIR| SINGULAIR 10MG QD