BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ISO-GARD HEPA SMALL STRAIGHT FILTER

    MDR report key: 2013806 · Received February 3, 2011

    Report

    Report Number
    8040412-2011-00016
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. SAMPLE HAS NOT BEEN RETURNED TO MFR IN TIME FOR THIS REPORT. A F/U INVESTIGATION WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT REPORTED AS: A SMALL UNIDENTIFIED MATERIAL (CELLULOSE) WAS FOUND INSIDE THE FILTER. THE MATERIAL WAS FOUND PRIOR TO USE AND MEASURED 0.25 CM. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ISO-GARD HEPA SMALL STRAIGHT FILTER HEPA FILTER CAH TELEFLEX MEDICAL NA 02390 CF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK