BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAIN BUSTER

    MDR report key: 748708 · Received August 1, 2005

    Report

    Report Number
    MW1036162
    Event Type
    Other
    Date Received
    August 1, 2005
    Date of Event
    March 1, 2005
    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 RIGHT ELBOW SURGERY UNEVENTFULLY BUT DEVELOPED A POST-OPERATIVE LIVER INFLAMMATION. WE ARE CONCERNED THAT THE POST-OP PUMP MIGHT POSSBILY BE A CAUSITIVE FACTOR. PT ALSO REC'D IV ANCEF 1 GM, PROPOFOL 760 MG, FENTANYL 100 MCG, MIDAZOLAM 2 MG. UPPER EXTREMITY BLOCK WITH 22.5 CC 0.5% BUPIVICAINE AND 22.5 CC 1.5% MEPIVICAINE. PRESCRIPTION FOR VICODIN FOR POST-OP PAIN GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN BUSTER POST-OPERATIVE PAIN PUMP MEB I-FLOW PM024 4B2710

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other FENTANYL 100 MCG| PROPOFOL 760 MG| ANCEF 1 GM| MIDAZOLAM 2 MG.| UPPER EXTREMITY BLOCK WITH 22.5 CC 0.5%| PRESCRIPTION FOR VICODIN FOR POST-OP PAIN GIVEN.| BUPIVICAINE AND 22.5 CC 1.5% MEPIVICAINE