BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1010132 · Received March 7, 2008

    Report

    Report Number
    2026095-2008-00017
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 7, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER INDICATED THAT NO SAMPLE WAS AVAILABLE FOR EVAL AND INVESTIGATION. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORTER STATED THAT THE PT HAD DEVELOPED SEVERE JOINT CARTILAGE DAMAGED (CHONDROLYSIS). NO PROBLEMS WITH THE OPERATION OF THE PUMP WERE REPORTED. IN LATE 2006, IN LIGHT OF THE POSSIBLE CONNECTION BETWEEN THE USE OF BUPIVACAINE IN THE INTRA-ARTICULAR SPACE AND THE ONSET OF CHONDROLYSIS AS SUGGESTED BY THE LITERATURE, AND IN AN ABUNDANCE OF CAUTION, I-FLOW MODIFIED THE ON-Q DIRECTIONS FOR USE (DFU) BY ADDING THIS WARNING: "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." IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD DEVELOPED SEVERE JOINT CARTILAGE DAMAGE FOLLOWING SURGERY FOR AN OPEN INFERIOR CAPSULAR SHIFT THE USE OF AN ON-Q PUMP.

    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 Other| S