BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 2762482 · Received September 24, 2012

    Report

    Report Number
    2026095-2012-00234
    Event Type
    Injury
    Date Received
    September 24, 2012
    Date of Event
    March 8, 2004
    Report Date
    August 24, 2012
    Manufacturer
    I-FLOW, LLC
    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. RESULT: THE INFO CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW, LLC. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE U.S. FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. 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 OR THREATENED LITIGATION." AS OF 11/09/2006, I-FLOW UPDATED THE ON-Q PUMP DIRECTIONS FOR USE (DFU), TO INCLUDE THE FOLLOWING IN THE WARNINGS SECTION: "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). ON 08/08/2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV E).

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK, FILL VOLUME: UNK, FLOW RATE: UNK, PROCEDURE: RIGHT SHOULDER SURGERY, CATHPLACE: RIGHT SHOULDER. PT ALLEGES DEGENERATION OF SHOULDER CARTILAGE FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER PUMP AFTER SURGERY ON (B)(6), 2004.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other