BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1355356 · Received March 30, 2009

    Report

    Report Number
    2026095-2009-00060
    Event Type
    Other
    Date Received
    March 30, 2009
    Date of Event
    June 29, 2006
    Report Date
    March 6, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFORMATION CONCERNING THE PUMP, PROCEDURE, OR OTHER PARTICULARS OF THE ALLEGED INCIDENT. WITHOUT THE ACTUAL PRODUCT OR DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. 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 CASUAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU REV. G). IT WAS ALSO REPORTED THAT EPINEPHRINE WAS USED IN THE PUMP. THE DIRECTIONS FOR USE FOR THE PAINBUSTER PUMP CONTAINS A WARNING THAT STATES: "VASOCONSTRICTORS SUCH AS EPINEPHRINE ARE NOT RECOMMENDED FOR CONTINUOUS INFUSIONS." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (REV. E). IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PATIENT ALLEGES THAT HE SUFFERED LOSS OF CARTILAGE AND A NARROWING OF THE JOINT SPACE AND/OR A CONDITION CALLED "CHONDROLYSIS" WHICH IS THE COMPLETE OR NEARLY COMPLETE LOSS OF CARTILAGE IN THE SHOULDER JOINT, FOLLOWING THE USE OF A PAIN PUMP IN SURGERY IN 2006.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention