BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER ADAPTOR, 033, STERILE

    MDR report key: 1963597 · Received December 21, 2010

    Report

    Report Number
    1417411-2010-00056
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 8, 2010
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, THE 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: AIR LEAK FOUND AT THE SETTINGS PRIOR TO USE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEBULIZER ADAPTOR, 033, STERILE NEBULIZER ADAPTOR CAF TELEFELX MEDICAL NA D19033

    Patients

    Seq Age Sex Outcome Treatment
    1