BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAIN BUSTER

    MDR report key: 748655 · Received August 1, 2005

    Report

    Report Number
    MW1036159
    Event Type
    Other
    Date Received
    August 1, 2005
    Date of Event
    October 20, 2004
    Report Date
    July 27, 2005
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD SHOULDER SURGERY UNEVENTFULLY AND DEVELOPED A POST-OPERATIVE LIVER INFLAMMATION. HE HAD AN ON-Q PAIN BUSTER REF#PM014, LOT #472104, PUMP PLACED FOR POST-OPERATIVE PAIN RELIEF. ALSO REC'D IV, ANCEF 1 GRAM, PROPOFOL 1020 MG, KETORALAC 30 MG, FENTANYL 100 MCG, MIDAZOLAM 2 MG, MEPERIDINE 12.5 MG. UPPER EXTREMITY BLOCK WITH 30 CC 0.5% BUPIVICAINE AND 30 CC 1.5% MEPIVICAINE. ON-Q PAIN BUSTER PUMP FILLED WITH 270 CC 0.5% BUPIVICAINE AT 5 CC/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN BUSTER POST-OPERATIVE PAIN PUMP MEB I-FLOW PM014 472104

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other