BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON Q PAINBUSTER SOAKER

    MDR report key: 1696433 · Received May 14, 2010

    Report

    Report Number
    1696433
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 14, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    SPLIT INTRODUCER CATHETER SPLIT TRANSVERSE TO THE CATHETER IMPLANTED, INSTEAD OF LONGITUDINALLY PARALLEL TO THE CATHETER. IT ALSO DISINTEGRATED INTO PIECES WHEN RETRIEVAL ATTEMPTS WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON Q PAINBUSTER SOAKER PUMP, INFUSION, ELASTOMERIC MEB I-FLOW CORPORATION * 7B2886

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR