BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 2520444 · Received April 4, 2012

    Report

    Report Number
    2026095-2012-00058
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    May 18, 2005
    Report Date
    November 1, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVAL AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFO CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW CORPORATION. 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 1307011). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." (1303722, REV. E). CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE W/EPINEPHRINE; FILL VOLUME: UNK; FLOW RATE: UNK; PROCEDURE: LABRUM CARTILAGE DEFECT ON RIGHT SHOULDER CATHPLACE: SHOULDER JOINT. PT ALLEGES CHONDROLYSIS FOLLOWING PLACEMENT OF AN I-FLOW PAINBUSTER AFTER SURGERY ON (B)(6) 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other