BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1849081 · Received September 23, 2010

    Report

    Report Number
    2026095-2010-00242
    Event Type
    Other
    Date Received
    September 23, 2010
    Date of Event
    July 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    FAST FLOW. PUMP INFUSED IN 1 HR INSTEAD OF 2 HRS. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. ST 400-2 842651

    Patients

    Seq Age Sex Outcome Treatment
    1