BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST NEBULIZER W/TEE

    MDR report key: 2160203 · Received June 2, 2011

    Report

    Report Number
    3004365956-2011-00226
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REPORTED AS: THE NEBULIZER WOULD NOT MIST. THE ALLEGED DEFECT WAS DISCOVERED DURING TREATMENT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON MICRO MIST NEBULIZER W/TEE SMALL VOLUME NEBULIZER CAF TELEFLEX MEDICAL NA 02B1101562

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK