BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1132483 · Received August 19, 2008

    Report

    Report Number
    2026095-2008-00113
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    January 3, 2002
    Report Date
    July 21, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE PROD WAS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PROD, PART NUMBER, LOT NUMBER, OR DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. THE MEDWATCH INDICATED THAT AN ADVERSE EVENT HAD OCCURRED WITH AN OUTCOME OF DISABILITY OR PERMANENT DAMAGE, SO THIS MDR IS BEING FILED. NO CONFIRMATION THAT THE PROD WAS MFG BY I-FLOW WAS PROVIDED. THE ON-Q PUMP DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY" THAT IS AVAILABLE. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    IN 2002, ARTHROSCOPIC SURGERY FOR RIGHT SHOULDER LABRAL TEAR/SLAP WITH ANTERIOR INSTABILITY AND THERMAL CAPSULORRHAPHY. DR NOTED GLENOHUMERAL JOINT WAS FREE OF CHONDROMALACIA. IN 2006, X-RAYS REVEALED MODERATE GLENOHUMERAL DEGENERATIVE JOINT DISEASE IN RIGHT SHOULDER. IN 2007, X-RAYS REVEALED RIGHT SIDE SEVERE GLENOHUMERAL JOINT SPACE NARROWING WITH POSITIVE PERIPHERAL OSTEOPHYTE SEEN AT THE INFERIOR HUMERAL HEAD AND MEDIAL INFERIOR GLENOID. FILL VOLUME 100ML. CONTACT ANONYMOUS. MEDWATCH HAS "ADVERSE EVENT" CHECKED, OUTCOME IS DISABILITY OR PERMANENT DAMAGE. IMPLANT DATE OF 2002, AND AN EVENT DATE IN THE SAME YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INFUSION PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability BUPIVACAINE 0.5%