BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AEROSOL POCKET CHAMBER

    MDR report key: 1941987 · Received November 8, 2010

    Report

    Report Number
    1044475-2010-00152
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    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 DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: SOME OF THE MEDICATION IS LOST THROUGH THE SILICONE VALVE BEFORE THE PATIENT INHALES, WHICH RESULTS IN THE PATIENT NOT GETTING ALL OF THEIR MEDICATION. AEROSOL WOULD NOT EXIT EACH AND EVERY TIME. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AEROSOL POCKET CHAMBER AEROSOL POCKET CHAMBER CCQ TELEFLEX MEDICAL NA 520809

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK