BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVIZION FEEDING TUBE PLACEMENT SYSTEM

    MDR report key: 18700351 · Received February 13, 2024

    Report

    Report Number
    3017081712-2024-00001
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 14, 2024
    Report Date
    February 13, 2024
    Manufacturer
    ENVIZION MEDICAL LTD.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A LUNG PLACEMENT RESULTING IN A PNEUMOTHORAX OCCURRED ON (B)(6) 2024. COMPANY MADE AWARE ON 15JAN2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60630 ENVIZION FEEDING TUBE PLACEMENT SYSTEM NG FEEDING TUBE KNT ENVIZION MEDICAL LTD. ENV-20000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| L| H