BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1980240 · Received February 2, 2011

    Report

    Report Number
    2026095-2011-00003
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    July 1, 2007
    Report Date
    January 10, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBERS WERE NOT PROVIDED, SO THE LOT AND DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORTER DID NOT PROVIDE ANY SPECIFIC INFO CONCERNING THE 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. L). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." (1303722, REV. E). 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

    PT ALLEGEDLY SUFFERED A NARROWING OF THE JOINT SPACE AND A CONDITION CALLED "CHONDROLYSIS" IN HER SHOULDER JOINT, FOLLOWING THE USE OF A PAIN PUMP AFTER SURGERY IN (B)(6) OF 2007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other