BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q LARGE, I-FLOW

    MDR report key: 1071552 · Received July 9, 2008

    Report

    Report Number
    MW5007554
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    April 7, 2003
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, RIGHT - ARTHROSCOPIC SLAP REPAIR, CAPSULAR PLICATION USING SUTURES AND THERMAL, BURSECTOMY, PAIN PUMP PLACEMENT ON-Q LARGE IN GLENOHUMERAL SPACE. ON APPROX FOUR MONTHS LATER, RIGHT ARTHROSCOPIC EXPLORATION, DEBRIDEMENT OF BICEPS STUMP AND GLENOID ARTICULAR SURFACE, OPEN BICEPS TENODESIS. IN 2006, RIGHT SHOULDER DEGENERATIVE JOINT DISEASE, RIGHT TOTAL SHOULDER ARTHROPLASTY. DOSE OR AMOUNT: 250CC. FREQUENCY: UNK. ROUTE: 014. DATES OF USE: 2003. DIAGNOSIS OR REASON FOR USE: RIGHT SUPERIOR LABRAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q LARGE, I-FLOW ON-Q LARTE, I-FLOW MEB I-FLOW CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% MARCAINE WITH EPINEPHRINE 1:200