BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1311845 · Received February 9, 2009

    Report

    Report Number
    1722139-2009-00004
    Event Type
    Injury
    Date Received
    February 9, 2009
    Date of Event
    January 8, 2008
    Report Date
    February 5, 2009
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. THE COMPANY HAS ATTEMPTED TO HAVE THE CUSTOMER RETURN THE DEVICE WITHOUT SUCCESS. UPON RECEIPT OF THE DEVICE, MOOG MEDICAL DEVICES GROUP WILL COMPLETE AN EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE CUSTOMER: "PARENT REPORTS THE PUMP DID NOT DELIVER AND CHILD HAS BEEN HOSPITALIZED AND IN SERIOUS CONDITION. THE MOTHER REPORTS THINKING THE PUMP WAS DELIVERING, BUT WHEN SHE RETURNED, THE PUMP HAD DELIVERED NO FOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other