BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1132543 · Received August 19, 2008

    Report

    Report Number
    2026095-2008-00115
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    March 8, 2008
    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 ACTUAL DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. THE MEDWATCH INDICATED THAT THE PT HAD ARTHROSCOPIC SURGERY 2004, FOR A RIGHT SHOULDER SLAP TEAR WITH MILD INSTABILITY. AN ON-Q CONTROL SYS WAS INTRODUCED INTO THE GLENHUMERAL JOINT. IN 2006, CHONDROLYSIS OF RIGHT SHOULDER WAS REPORTED. NO CONFIRMATION WAS PROVIDED THAT THIS PROD WAS MFG BY I-FLOW. 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

    IT WAS REPORTED ON MEDWATCH REPORT THAT THE PT HAD ARTHROSCOPIC SURGERY FOR RIGHT SHOULDER SLAP TEAR WITH MILD INSTABILITY. AN ON-Q CONTROL SYS WAS INTRODUCED INTO THE GLENOHUMERAL JOINT. IN 2006, CHONDROLYSIS OF RIGHT SHOULDER WAS REPORTED.

    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 0.5% MARCAINE PLAIN