BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1466312 · Received September 3, 2009

    Report

    Report Number
    2026095-2009-00239
    Event Type
    Other
    Date Received
    September 3, 2009
    Report Date
    August 27, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFO CONCERNING THE PUMP, 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 (IFU) 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 1304265, REV. G). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. E). IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. CONCLUSION: AS A RESULT OF THE CAPA ASSESSMENT ((B)(4)), I-FLOW CORPORATION IS REQUESTING AN RAE FOR REPORTS AND/OR ALLEGATIONS OF CHONDROLYSIS (E.G, CARTILAGE ISSUES) THAT ARE ENTERED INTO THE COMPLAINT DATABASE THAT MEETS THE MDR REPORTING REQUIREMENT GENERATED THROUGH THE SERVICE OF LEGAL COMPLAINTS TO I-FLOW RELATED TO CHONDROLYSIS.

    Description of Event or Problem · 1

    PT ALLEGES THAT HE SUFFERED A NARROWING OF THE JOINT SPACE AND/OR A CONDITION CALLED "CHONDROLYSIS" WHICH IS THE COMPLETE OR NEARLY COMPLETE LOSS OF CARTILAGE IN THE SHOULDER JOINT, FOLLOWING THE USE OF A PAIN PUMP AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INFUSION PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention