BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOMED ENTERAL FEEDING TUBE

    MDR report key: 8514521 · Received April 15, 2019

    Report

    Report Number
    3006520777-2019-00003
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 16, 2019
    Report Date
    April 15, 2019
    Manufacturer
    NEOMED, INC
    Product Code
    FPD
    UDI-DI
    00817584012837
    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

    THIS REPORT IS IN RESPONSE TO MEDWATCH USER FACILITY REPORT # (B)(4).

    Description of Event or Problem · 1

    GASTRIC PERFORATION WAS IDENTIFIED IN A SEXTUPLET NICU PATIENT (PATIENT IDENTIFIER: (B)(6)) AFTER SIGNS AND SYMPTOMS OF ABDOMINAL DISTENTION. GASTRIC PERFORATION WAS IDENTIFIED AND CORRECTED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307703 NEOMED ENTERAL FEEDING TUBE TUBE, FEEDING FPD NEOMED, INC PFTM8.0P-EO 20180825 00817584012837

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention