BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAIN BUSTER

    MDR report key: 748719 · Received August 1, 2005

    Report

    Report Number
    MW1036163
    Event Type
    Other
    Date Received
    August 1, 2005
    Date of Event
    April 28, 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 UNEVENTFUL SHOULDER SURGERY BUT DEVELOPED POST-OPERATIVE CHEST PAIN AND LIVER INFLAMMATION. PT ALSO REC'D IV ANCEF 1 GM, FENTANYL 150 MCG, MIDAZOLAM 2 MG, PROPOFOL 895 MG. UPPER EXTREMITY BLOCK WITH 15 CC 0.5% BUPIVICAINE AND 15CC 1.5% MEPIVICAINE. PERCOCET FOR POST-OP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN BUSTER POST-OPERATIVE PAIN PUMP MEB I-FLOW PM014 4C2825

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other BUPIVICAINE AND 15 CCC 1.5% MEPIVICAINE.| PROPOFOL 895 MG| FETANYL 150 MCG| UPPER EXTREMITY BLOCK WITH 15 CC 0.5%| ANCEF 1 GM| PERCOCET FOR POST-OP PAIN.| MIDAZOLAM 2 MG