BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST NEBULIZER W/TUBING

    MDR report key: 2121747 · Received May 20, 2011

    Report

    Report Number
    3004365956-2011-00208
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 6, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE NEBULIZER IS DISPLAYING AN ERRATIC AND INADEQUATE PERFORMANCE DURING USE ON A PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON MICRO MIST NEBULIZER W/TUBING MICRO MIST NEBULIZER CAF TELEFLEX MEDICAL NA 02A1100974

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK