BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERALITE AMBULATORY ENTERAL FEEDING PUMP

    MDR report key: 1731222 · Received June 17, 2010

    Report

    Report Number
    1722139-2010-00067
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    April 21, 2010
    Report Date
    June 3, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K954735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: PUMP HEATS UP WHILE IN BACKPACK TO THE POINT THE FORMULA GETS HOT AND BACTERIAL MATTER BUILDS UP CAUSING THE CHILD TO BECOME ILL. PATIENT INJURY? YES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1