BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST NEBULIZER

    MDR report key: 2941263 · Received January 16, 2013

    Report

    Report Number
    3004365956-2013-00038
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 30, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE TECHNICAL STAFF WENT INTO THE HOSPITAL AND TOOK SAMPLE OF A DEVICE AND DETECTED A LEAK IN THE SUPPLY TUBING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25281 HUDSON MICRO MIST NEBULIZER MICRO MIST NEBULIZER CAF TELEFLEX MEDICAL 02F1201615

    Patients

    Seq Age Sex Outcome Treatment
    1