BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN BUSTER

    MDR report key: 1071591 · Received July 9, 2008

    Report

    Report Number
    MW5007579
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    July 14, 2004
    Report Date
    July 2, 2008
    Manufacturer
    DJ ORTHOPEDICS, 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

    RT. SHOULDER ARTHROSCOPIC SURGERY IN 2004, TO REPAIR LABRAL SLAP LESION AND ARTHROSCOPIC SUBACROMIAL DECOMPRESSION. PLACEMENT OF PAIN PUMP CATHETER SUBACROMIAL SPACE AND PLACEMENT OF PAIN PUMP CATHETER GLENOHUMERAL SPACE. AT THE TIME OF SURGERY: GLENOID AND HUMERUS ARTICULAR CARTILAGE SHOWED NO DEGENERATIVE CHANGES OR WEAR. PAIN PUMP REFILLED 2 DAYS LATER. IN 2005, HAD SURGERY FOR ADHESIVE CAPSULITIS, GRADE 3 CHONDROMALACIA OF THE ENTIRE GLENOHUMERAL CONTACT SURFACE, AND INTRAARTICULAR SCARIFICATION. PLACEMENT OF PAIN PUMP CATHETER GLENOHUMERAL SPACE X 2. FINAL RESULT: RIGHT SHOULDER TOTAL ARTHROPLASTY ABOUT 8 MONTHS LATER. DOSE OR AMOUNT #1 - 270 ML. FREQUENCY: 4 ML/HR. ROUTE: 014. DOSE OR AMOUNT #2 - 200 CC REFILL, 0.25%. DATES OF USE: 2004. DIAGNOSIS OR REASON FOR USE #1 - ANTERIOR SUPERIOR LABRAL TEAR. DIAGNOSIS OR REASON FOR USE #2 - SUBACROMIAL BURSITIS-RT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN BUSTER PAIN BUSTER DUAL PAIN MANAGEMENT MEB DJ ORTHOPEDICS, LLC 362425

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability 0.5% MARCAINE W/EPINEPHRINE