BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTRIFLEX FEEDING TUBE

    MDR report key: 392226 · Received May 1, 2002

    Report

    Report Number
    1314412-2002-00004
    Event Type
    Other
    Date Received
    May 1, 2002
    Report Date
    May 1, 2002
    Manufacturer
    THE KENDAL COMPANY
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ON TWO OCCASSIONS THE END USER PERFORATED THE PLEURAL TISSUE UPON PASSING A FEEDING TUBE. KENDALL RECEIVED NOTIFICATION OF THE EVENTS ON 04/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRIFLEX FEEDING TUBE FEEDING TUBE FPD THE KENDAL COMPANY * 131815

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention