BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 1579928 · Received January 8, 2010

    Report

    Report Number
    2026095-2009-00293
    Event Type
    Other
    Date Received
    January 8, 2010
    Date of Event
    May 24, 2007
    Report Date
    December 15, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1304265, REV. K). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, 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 ALLEGEDLY SUFFERED A NARROWING OF THE JOINT SPACE AND/OR A CONDITION CALLED "GLENOHUMERAL CHONDROLYSIS", FOLLOWING THE USE OF PAIN PUMP AFTER SURGERY ON (B) (6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORPORATION PM014 682072

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention