BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1071572 · Received July 9, 2008

    Report

    Report Number
    MW5007573
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    March 22, 2004
    Report Date
    July 2, 2008
    Manufacturer
    MCKINLEY MEDICAL
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2004, SHOULDER SURGERY- ARTHROSCOPIC REPAIR OF LABRAL TEAR, FLAP TEAR. PLACEMENT PAIN PUMP CATHETER SUBACROMIAL SPACE AND GLENOHUMERAL SPACE; FILLED WITH MARCAINE WITH EPINEPHRINE- 0.5%; 270 CC 1:200, 000. 2004: PUMP REFILL: MARCAINE 0.25%, W/ EPINEPHRINE 1:200,000, 50 CC X 5 VIALS- 250 CC. 2005: MRI REVEALED: DEGENERATIVE CHANGE ON BOTH SIDES OF THE JOINT. 2006: MRI FINDINGS: THERE IS NEW HIGH GRADE THINNING OF HYALINE CARTILAGE ON BOTH SIDES OF THE GLENOHUMERAL JOINT, THROUGHOUT THE JOINT. 2007: TOTAL SHOULDER REPLACEMENT. DOSE OR AMOUNT: 270 CC 1:200,000. FREQUENCY: 2X2 ML/HR. ROUTE: 014. DATES OF USE: 2004. DIAGNOSIS OR REASON FOR USE: #1: REPAIR OF LABRAL TEAR, #2: REPAIR OF FLAP TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DONJOY PAIN MGMT MEB MCKINLEY MEDICAL * 60526871

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% MARCAINE W/EPINEPHRINE