BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERAL FEEDING TUBE

    MDR report key: 8567084 · Received April 30, 2019

    Report

    Report Number
    3006520777-2019-00006
    Event Type
    Injury
    Date Received
    April 30, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEOMED HAS CONTACTED USER FACILITY FOR ADDITIONAL INFORMATION REGARDING THIS EVENT (B)(6)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
    360485 ENTERAL FEEDING TUBE FPD NEOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention