BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW, ON-Q PAINBUSTER, 270 ML PAIN PUMP

    MDR report key: 1071550 · Received July 9, 2008

    Report

    Report Number
    MW5007552
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    August 2, 2004
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOSS OF ARTICULAR CARTILAGE WITH CHONDROLYSIS, REQUIRING RIGHT SHOULDER HEMIARTHROPLASTY. DOSE OR AMOUNT: .5/.25 % SENSORCAINE. FREQUENCY: 270 ML, 5 ML/HR. ROUTE: 014. DATES OF USE: 2004. DIAGNOSIS OR REASON FOR USE: ARTHROSCOPY RT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW, ON-Q PAINBUSTER, 270 ML PAIN PUMP PAINBUSTER PAIN PUMP MEB I-FLOW 442498

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Disability 0.25% SENSORCAINE 150 CC| 0.5 % SENSORCAINE 150 CC