BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FLOW

    MDR report key: 490933 · Received October 21, 2003

    Report

    Report Number
    490933
    Event Type
    Malfunction
    Date Received
    October 21, 2003
    Date of Event
    October 9, 2003
    Report Date
    October 17, 2003
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON Q PUMP LEAKING EXTERNALLY AT THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW ON Q SOAKER MEB I-FLOW CORPORATION PM015 .372605

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other