BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN BUSTER SOAKER 6.5, 100ML VOLX2ML/HR

    MDR report key: 2465254 · Received February 21, 2012

    Report

    Report Number
    2026095-2012-00012
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    July 6, 2006
    Report Date
    January 23, 2012
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVAL AND INVESTIGATION. RESULTS: THE INFO CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW CORP. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL 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 (B)(4)). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." ((B)(4), REV E). CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW OR THE THREAT OF A LAWSUIT, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE 0.5%, FILL VOLUME: 100 ML, FLOW RATE: 2 ML/HR, PROCEDURE: RIGHT SHOULDER ARTHROSCOPIC SURGERY, CATHPLACE: SHOULDER JOINT. PT ALLEGES GLENOHUMERAL CHONDROLYSIS FOLLOWING PLACEMENT OF AN I-FLOW ON-Q PAINBUSTER PUMP AFTER SURGERY ON (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN BUSTER SOAKER 6.5, 100ML VOLX2ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. 5001361 642472

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other