BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1133963 · Received August 19, 2008

    Report

    Report Number
    2026095-2008-00112
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    December 19, 2003
    Report Date
    July 21, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE PRODUCT WAS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, PART NUMBER, LOT NUMBER, OR DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. THE MEDWATCH INDICATED THAT AN ADVERSE EVENT HAD OCCURRED WITH AN OUTCOME OF DISABILITY OR PERMANENT DAMAGE, SO THIS MDR IS BEING FILED. NO CONFIRMATION THAT THE PRODUCT WAS MFG BY I-FLOW WAS PROVIDED. 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." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY" THAT IS AVAILABLE. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IN 2003, LEFT SHOULDER ARTHROSCOPY FOR INSTABILITY, LABRAL DEBRIDEMENT, AND ANTERIOR SHOULDER CAPSULORRHAPHY. PUMP CATHETER INSERTED IN THE JOINT. IN 2006, MASSIVE CHRONDROLYSIS IN LEFT SHOULDER. FILL VOLUME 300ML OVER 3 DAYS. MEDWATCH HAS "ADVERSE EVENT" CHECKED, OUTCOME IS DISABILITY OR PERMANENT DAMAGE. IMPLANT DATE OF LATE 2003, EXPLANT DATE OF THREE DAYS LATER, AND AN EVENT DATE OF 2003. NO OTHER INFO IS PROVIDED.

    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 28 YR Disability MARCAINE 0.5%