BEUDAMED
    FDA Adverse Event Summary report: N

    NEBULIZERS TO DELIVER AEROSOLS

    MDR report key: 2853689 · Received December 3, 2012

    Report

    Report Number
    1531186-2012-01565
    Date Received
    December 3, 2012
    Report Date
    December 1, 2012
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), THE DEALER REPORTED THAT THE IRC1740 TEDDY BEAR NEBULIZER HAD LOW PRESSURE OUTPUT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEBULIZERS TO DELIVER AEROSOLS 868.5630 CAF EMG TECHNOLOGY CO. LTD IRC1740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other