BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVUE® ENTERAL FEEDING TUBES

    MDR report key: 17451002 · Received August 3, 2023

    Report

    Report Number
    3017081712-2023-00002
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    May 22, 2023
    Report Date
    August 3, 2023
    Manufacturer
    ENVIZION MEDICAL, LTD.
    Product Code
    KNT
    UDI-DI
    B483ENV200000
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A LUNG PLACEMENT OCCURRED ON (B)(6) 2023. INTERVENTION WAS REQUIRED TO REMOVE THE FEEDING TUBE FROM THE LUNG TO PREVENT INJURY. BASED ON THE INFORMATION PROVIDE NO ACTUAL INJURY OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507387 ENVUE® ENTERAL FEEDING TUBES NG FEEDING TUBE KNT ENVIZION MEDICAL, LTD. ENV-2000 N/A B483ENV200000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention