BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOMED

    MDR report key: 8479497 · Received March 27, 2019

    Report

    Report Number
    8479497
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    March 16, 2019
    Report Date
    March 27, 2019
    Manufacturer
    NEOMED, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GASTRIC PERFORATION IDENTIFIED AFTER THE BABY SHOWED SIGNS AND SYMPTOMS OF ABDOMINAL DISTENTION. PERIODOGRAM REVEALED INTRA-ABDOMINAL AIR. PEDIATRIC SURGERY CONSULTED. GASTRIC PERFORATION IDENTIFIED AND CORRECTED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248296 NEOMED ENTERAL FEEDING TUBE FPD NEOMED, INC. 20180825

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention