BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DON JOY PAINBUSTER

    MDR report key: 1071585 · Received July 9, 2008

    Report

    Report Number
    MW5007577
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    September 10, 2003
    Report Date
    July 2, 2008
    Manufacturer
    DONJOY, INC., 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

    CHONDROLYSIS RIGHT GLENOHUMERAL JOINT. LOSS OF ARTICULAR CARTILAGE ON BOTH THE HUMERAL AND GLENOID SIDES WITH BONE ON BONE APPOSITION RADIOGRAPHICALLY, ASSOCIATED MARKED RESTRICTED PAINFUL MOTION, AND MARKED PAIN WITH DAILY ACTIVITIES REQUIRING NARCOTICS. LOSS OF CARTILAGE, TOTAL SHOULDER REPLACEMENT REQUIRED IN 2007. DOSE OF AMOUNT: 0.5%, FREQUENCY: 270 ML, 4 ML / HR, ROUTE: 014. DATES OF USE: 2003 FOR APPROX 48 HRS. DIAGNOSIS OR REASON FOR USE:. RT SHOULDER ARTHROSCOPY, 726.10 - TENDONITIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DON JOY PAINBUSTER PAINBUSTER DUALPAIN MANAGEMENT; 270 ML, 4 ML/ HR MEB DONJOY, INC., DJO, LLC 362505

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability MARCAINE WITH EPINEPHRINE