BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP

    MDR report key: 2343465 · Received November 16, 2011

    Report

    Report Number
    2026095-2011-00372
    Event Type
    Injury
    Date Received
    November 16, 2011
    Date of Event
    June 8, 2009
    Report Date
    October 26, 2011
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFORMATION 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." (B)(4). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED (B)(4). CONCLUSION: AS THIS COMPLAINT WAS CREATED FORM 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: UNK. FILL VOLUME: UNK. FLOW RATE: UNK. PROCEDURE: SHOULDER SURGERY. CATHPLACE: SHOULDER. (REFERENCE 2026095-2011-371) PT ALLEGES DEGENERATION OF SHOULDER CARTILAGE FOLLOWING PLACEMENT OF AN I-FLOW PAIN PUMP AFTER SURGERY ON OR ABOUT (B)(6) 2009.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other