BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERAL FEEDING TUBE

    MDR report key: 8737034 · Received June 26, 2019

    Report

    Report Number
    3006520777-2019-00005
    Event Type
    Injury
    Date Received
    June 26, 2019
    Report Date
    April 30, 2019
    Manufacturer
    NEOMED, INC.
    Product Code
    FPD
    PMA / PMN Number
    K082238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEOMED HAS CONTACTED USER FACILITY FOR ADDITIONAL INFORMATION REGARDING THIS EVENT 16 APRIL 2019, 24 APRIL 2019, AND 30 APRIL 2019. ADDITIONAL INFORMATION HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A PERFORATION WAS IDENTIFIED IN A NEONATAL PATIENT WHO HAD A NEOMED POLYURETHANE FEEDING TUBE PLACED FOR GASTRIC VENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529154 ENTERAL FEEDING TUBE FPD NEOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention