BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 1132523 · Received August 19, 2008

    Report

    Report Number
    2026095-2008-00116
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    December 30, 2004
    Report Date
    July 21, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE PROD WAS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PROD, OR DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. THE MEDWATCH INDICATED THAT AN ADVERSE EVENT HAD OCCURRED WITH AN OUTCOME OF DISABILITY OR PERMANENT DAMAGE, SO THIS MDR IS BEING FILED. A REVIEW OF LOT HISTORY FOUND NO OTHER COMPLAINTS FOR LOT 4A2530.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 (PARTICULARY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY" THAT IS AVAILABLE IF ADDITIONAL INFORMATION THAT IS PERTINEENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    MEDWATCH HAS "ADVERSE EVENT" CHECKED, OUTCOME IS DISABILITY OR PERMANENT DAMAGE. IMPLANT DATE OF 2004, EXPLANT DATE OF 2005, AND AN EVENT DATE OF 2004. NO OTHER INFO IS PROVIDED. UPDATE 2008: LEFT SHOULDER DEBRIDEMENT AND REPAIR. ARTICULAR SURFACES NORMAL. PUMP PLACEMENT IN SHOULDER JOINT. IN 2006 - LEFT SHOULDER SURGERY. RADIOGRAPHS LEFT SHOULDER SHOW END STAGE JOINT SPACE NARROWING. MRI SHOWS EVIDENCE OF CENTRAL GLENOHUMERAL NARROWING WITH OSTEOPHYTE FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORP. PM014 4A2530

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability BUPIVACAINE 0.25%