BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW, ON-Q PAINBUSTER. 270 ML, 5ML/HR

    MDR report key: 1071578 · Received July 9, 2008

    Report

    Report Number
    MW5007575
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    December 30, 2004
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2004 - LABRAL TEAR, LEFT SHOULDER; ARTHROSCOPY, DEBRIDEMENT AND REPAIR. ARTICULAR SURFACES WERE NORMAL. PAIN PUMP PLACEMENT IN SHOULDER JOINT: I-FLOW, ON-Q PAIN BUSTER, 270 ML, 5 ML/HR. 2006 - LEFT SHOULDER SURGERY - DETAILS UNK. 2006 - RADIOGRAPHS LEFT SHOULDER - SHOW END STAGE JOINT SPACE NARROWING. 2006 LEFT SHOULDER MRI - SHOWS EVIDENCE OF CENTRAL GLENOHUMERAL NARROWING W/OSTEOPHYTE FORMATION. DOSE OR AMOUNT: 270 ML, FREQUENCY: 5 ML/HR, ROUTE: 014. DATES OF USE: 2004-2005. DIAGNOSIS OR REASON FOR USE: LABRAL TEAR, LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW, ON-Q PAINBUSTER. 270 ML, 5ML/HR ON-Q PAINBUSTER MEB I-FLOW REF: PM014 LOT# 4A2530

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability 0.5% BUPIVACAINE 150 CC| 0.25% BUPIVICAINE 150 CC