BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE 250ML, 175ML/HR

    MDR report key: 1972647 · Received January 21, 2011

    Report

    Report Number
    MW5019134
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE COMPOUNDING PROCESS, A HAIR WAS SEEN BETWEEN THE LAYERS OF THE ELASTOMERIC INFUSION DEVICE. THE ELASTOMERIC WAS A HOMEPUMP ECLIPSE 250ML, 175ML/HR MADE BY I-FLOW. REF # (B)(4) PART # 5001070 LOT # OB2704. IT DID NOT LEAVE THE PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ECLIPSE 250ML, 175ML/HR NONE MEB I-FLOW CORP. OB2704

    Patients

    Seq Age Sex Outcome Treatment
    1