BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO-ULTRA LITE

    MDR report key: 351201 · Received September 13, 2001

    Report

    Report Number
    351201
    Event Type
    Injury
    Date Received
    September 13, 2001
    Date of Event
    August 4, 2001
    Report Date
    September 11, 2001
    Manufacturer
    CORPAK MED SYSTEMS, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WITH A TRACH WAS BEING PREPARED FOR DISCHARGE HOME. THE FAMILY MEMBER PLACED A CORPAC INTERNAL FEEDING TUBE INTO THE PT. THE PT BECAME IRRITABLE AFTER THE FEEDING. THE FEEDING TUBE WAS FOUND IN THE PLEURAL SPACE. A HOLE WAS FOUND IN THE LUNG, ALONG WITH 73CC OF MILKY WHITE FLUID. THE FLUID WAS REMOVED WITH A CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41888 CORFLO-ULTRA LITE INTERNAL FEEDING TUBE FPD CORPAK MED SYSTEMS, INC. CORFLO-ULTRA LITE 5162

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention