BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1133843 · Received August 19, 2008

    Report

    Report Number
    2026095-2008-00111
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    February 15, 2000
    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. IT WAS REPORTED THAT EPINEPHRINE WAS USED IN THE PUMP. THE DIRECTIONS FOR USE FOR THE PAINBUSTER PUMP CONTAINS A WARNING THAT STATES: "USE OF VASOCONSTRICTORS, SUCH AS EPINEPHRINE OR ADRENALINE, IS NOT NECESSARY AND MAY NOT BE RECOMMENDED FOR CONTINUOUS INFUSIONS." 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

    ARTHROSCOPIC LEFT BANKART REPAIR; THERMAL CAPSULORRHAPHY SHIFT WITH PAIN PUMP INSERTION AFTER SURGERY. LEFT SHOULDER TOTAL SHOULDER ARTHROPLASTY IN 2007. LOSS OF ALL CARTILAGE AND MARKED PAIN AND RESTRICTED MOVEMENT AND FUNCTION. MEDWATCH HAS "ADVERSE EVENT" CHECKED, OUTCOME IS DISABILITY OR PERMANENT DAMAGE. IMPLANT DATE OF 2000, EXPLANT DATE OF TWO DAYS LATER, AND AN EVENT DATE OF 2000. FILL VOLUME 120ML. CONTACT ANONYMOUS.

    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 UNKNOWN Disability WITH EPINEPHRINE| MITEK THERMAL PROBE| MARCAINE 0.5%