BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY PAIN MGMT

    MDR report key: 1071603 · Received July 9, 2008

    Report

    Report Number
    MW5007581
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    May 12, 2004
    Report Date
    July 2, 2008
    Manufacturer
    DJO, LLC
    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 2004 RT. SHOULDER SLAP LESION TEAR REPAIR, WITH PAIN PUMP FILLED WITH 0.5% MARCAINE WITH EPINEPHRINE. PAIN PUMP REMOVED ON FIVE DAYS LATER. ON APPROX FOUR MONTHS LATER: ARTHROSCOPIC SURGERY FOR OSTEOARTHRITIS, RIGHT SHOULDER, FAILURE OF SLAP REPAIR, CYSTIC CHANGE AT SUTURE ANCHOR SITES. INSERTION OF PAIN PUMP FILLED WITH 0.5% MARCAINE WITH EPINEPHRINE INTO THE GLENOHUMERAL JOINT SPACE. ARTHROSCOPIC FINDINGS: THE GLENOHUMERAL JOINT SHOWED EXTENSIVE GRADE III CHONDROMALACIA ON THE HUMERUS AND THE GLENOID ARTICULATING SURFACE. IN 2006: RIGHT TOTAL SHOULDER ARTHROPLASTY. DOSE OR AMOUNT: 275 ML. FREQUENCY: 2 X 2 ML/HR. ROUTE: 014. DATES OF USE: 2004. DIAGNOSIS OR REASON FOR USE: RT SHOULDER SLAP LESION TEAR. DONJOY PAIN MGMT AFTER RT. SHOULDER SURGERY IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DONJOY PAIN MGMT DONJOY PAIN MGMT MEB DJO, LLC 60526871

    Patients

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