BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1221824 · Received November 4, 2008

    Report

    Report Number
    2026095-2008-00182
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    June 28, 2004
    Report Date
    October 8, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFO 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 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". IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A PAIN PUMP WAS USED FOLLOWING PT'S SHOULDER SURGERY IN 2004, PT WAS LATER DIAGNOSED WITH NARROWING OF THE JOINT SPACE AND CHONDROLYSIS.

    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 UNK Required Intervention