BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOME PUMP/ECLIPSE

    MDR report key: 748943 · Received September 13, 2005

    Report

    Report Number
    MW1036616
    Event Type
    Other
    Date Received
    September 13, 2005
    Report Date
    September 13, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ELASTOMERIC INFUSION DEVICES MANUFACTURED BY I-FLOW CORPORATION LEAK AFTER THEY HAVE BEEN FILLED WITH MEDICATION AND TAKEN TO PATIENT HOME. ALL OF THE DEVICES WERE THE 100ML, 100ML/HR. WE HAVE WRITTEN THE COMPANY SEVERAL TIMES WITHOUT RESPONSE FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOME PUMP/ECLIPSE ELASTOMERIC INFUSION DEVICE MEB I-FLOW CORP. * 542479

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other