BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 4101639 · Received August 27, 2014

    Report

    Report Number
    2026095-2014-00143
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    October 15, 2004
    Report Date
    July 30, 2014
    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: THE PRODUCT WAS NOT RETURNED FOR AN 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, LLC. 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. CONCLUSIONS: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT RECEIVED BY I-FLOW, LLC; NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION. AS OF (B)(6) 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." ON (B)(6) 2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." ((B)(4).). INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUT PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK. FILL VOUME: UNK. FLOW RATE: UNK. PROCEDURE: ACL RECONSTRUCTION OF RIGHT KNEE. CATHPLACE: THE KNEE JOINT. PT ALLEGES CHONDROLYSIS IN KNEE FOLLOWING PLACEMENT OF A PAINBUSTER AFTER SURGERY ON (B)(6) 2004. THE PT STARTED USING THE PUMP ON (B)(6) 2004 AND STOPPED USING THE DEVICE ON (B)(6) 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522648 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other DON JOY ICEMAN COLD THERAPY