BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 2613469 · Received April 24, 2012

    Report

    Report Number
    2026095-2012-00061
    Event Type
    Injury
    Date Received
    April 24, 2012
    Date of Event
    October 9, 2003
    Report Date
    February 2, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED AND FOUND THAT THE PRODUCT MET MANUFACTURING SPECIFICATION PRIOR TO RELEASE. RESULTS: THE INFORMATION 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. CONCLUSIONS: 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. AS OF (B)(4) 2006, I-FLOW HAS UPDATED ITS 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 (B)(4) 2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY", ((B)(4)).

    Description of Event or Problem · 1

    DRUG / DILUENT: MARCAINE W/EPINEPHRINE. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: ARTHROSCOPIC SURGERY. CATHPLACE: SHOULDER JOINT. REFERENCE MAUDE REPORT: (B)(4). REFERENCE 2026095-2012-00060 ((B)(4)). PATIENT ALLEGES CHONDROLYSIS FOLLOWING PLACEMENT OF AN I-FLOW PAINBUSTER AFTER SURGERY ON (B)(6) 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC 5001267 382697

    Patients

    Seq Age Sex Outcome Treatment
    1 Other