BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO MIST NEBULIZER W/ELONGATED MASK

    MDR report key: 2093300 · Received April 15, 2011

    Report

    Report Number
    3004365956-2011-00146
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 24, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE DEVICE CANNOT BE USED DUE TO ATOMIZATION CORE WAS BLOCKED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO MIST NEBULIZER W/ELONGATED MASK NEBULIZER W/MASK CAF TELEFLEX MEDICAL NA 02G1002101

    Patients

    Seq Age Sex Outcome Treatment
    1