BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW, ON-Q PAIN BUSTER

    MDR report key: 1071556 · Received July 9, 2008

    Report

    Report Number
    MW5007558
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    May 18, 2006
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2006, LEFT SHOULDER ARTHROSCOPIC DEBRIDEMENT OF ROTATOR INTERVAL AND SYNOVECTOMY ON THE UNDERSURFACE; ON-Q PAIN PUMP CONTAINING 0.5% MARCAINE WAS INSERTED INTO THE JOINT ANTERIORLY. FINDINGS OF 2007 MRI: THERE ARE DEGENERATIVE CHANGES OF THE GLENOHUMERAL JOINT CHARACTERIZED BY NARROWING OF THE JOINT SPACE AT ITS MORE SUPERIOR ASPECT AND MARGINAL OSTEOPHYTE FORMATION ABOUT THE INFERIOR ASPECT OF THE HUMERAL HEAD. THERE IS NO SIGNIFICANT JOINT EFFUSION. DATES OF USE: 2006. DIAGNOSIS OR REASON FOR USE: ARTHROSCOPIC DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW, ON-Q PAIN BUSTER ON-Q PAINBUSTER MEB I-FLOW CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% MARCAINE