BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN BUSTER

    MDR report key: 1071561 · Received July 9, 2008

    Report

    Report Number
    MW5007563
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    March 8, 2004
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARTHROSCOPIC SURGERY FOR RIGHT SHOULDER SLAP TEAR W/ MILD INSTABILITY. ON-Q PAIN CONTROL SYSTEM WERE INTRODUCED INTO THE GLENOHUMERAL JOINT. IN 2006, CHONDROLYSIS OF RT SHOULDER. DOSE OR AMOUNT: 300 CC. ROUTE: 014. DATE OF USE: 2004. DIAGNOSIS OR REASON FOR USE: RT SHOULDER SLAP TEAR. RT SHOULDER INSTABILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% MARCAINE PLAIN