BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY PAIN MANAGEMENT

    MDR report key: 1071588 · Received July 9, 2008

    Report

    Report Number
    MW5007578
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    November 3, 2004
    Report Date
    July 2, 2008
    Manufacturer
    DOYJOY DIVISION OF SMITH NEPHEW
    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 - SHOULDER, ARTHROSCOPY; SLAP REPAIR, ARTICULAR CARTILAGE OF NUMERUS WAS NORMAL. THE ARTICULAR CARTILAGE OF THE GLENOID WAS NORMAL WITH THE EXCEPTION OF THE ANTERIOR-INFERIOR GLENOID. PAIN BUSTER PAIN PUMP CANNULAS WERE PLACED POSTERIORLY ... THE PAIN PUMP CATHETER WAS VERIFIED WORKING AFTER IT WAS FILLED W/ 1% LIDOCAINE PLAIN W/ NO PRESERVATIVE. THE CATHETERS WERE PUT IN PLACE W/A STERILE VI-DRAPE. IN 2007 - SHOULDER, ARTHROSCOPIC LEFT W/ DEBRIDEMENT, POSSIBLE MINI OPEN ROTATOR CUFF REPAIR, POSSIBLE LOOSE BODY REMOVAL. ARTHROSCOPIC FINDINGS: GLENOHUMERAL JOINT WAS REMARKABLE FOR FULL-THICKNESS LOSS OF ARTICULAR CARTILAGE ON THE VERY SUPERIOR PORTION OF THE GLENOID. THE INFERIOR PORTION WAS INTACT. THERE WAS A LARGE LOOSE BODY AND IT WAS ATTACHED TO THE INFERIOR LABRUM AND SMALL LOOSE BODY ATTACHED TO THE ANTEROINFERIOR LABRUM. THE LABRAL STITCHES WERE INTACT AND THE LABRAL REPAIR APPEARED SUCCESSFUL AS THE LABRAL CARTILAGE HAD REATTACHED. THERE WAS GRADE II TO III CHANGES IN THE REMAINDER OF THE ARTICULAR CARTILAGE OF THE GLENOID. THE HUMERUS HAD APPROXIMATELY 30% THICKNESS LOSS OF WEIGHTBEARING ARTICULAR CARTILAGE. PAIN PUMP PLACED IN THE SUBACROMIAL SPACE. DOSE OR AMOUNT: #1. 270 CC, #2. 120 CC. FREQUENCY: #1 AND #2. UNK, ROUTE: #1. 014. #2. 049. DATES OF USE: #1. 2004. #2 2007. DIAGNOSIS OR REASON FOR USE: LEFT SHLDR SLAP TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DONJOY PAIN MANAGEMENT PAINBUSTER PAIN PUMP DUAL CATHETER MEB DOYJOY DIVISION OF SMITH NEPHEW REF 11-1352-0-0000 60587289
    2 PAIN PUMP MEB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 1% XYLOCAINE| 120 ML - IN SUBACROMIAL SPACE PAIN PUMP| LEFT SHOULDER PAIN PUMP PLACED IN SUBACROMIAL| LEFT SHOULDER PAINBUSTER PAIN PUMP DUAL| 1% XYLOCAINE PLAIN| CATHETER PLACED.