BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1132163 · Received August 19, 2008

    Report

    Report Number
    2026095-2008-00114
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 4, 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, 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 ALSO 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 MANUFACTURED 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

    MEDWATCH RECEIVED WITH "ADVERSE EVENT" CHECKED; OUTCOME IS DISABILITY OR PERMANENT DAMAGE. IMPLANT DATE OF 2003, EXPLANT DATE OF THREE DAYS LATER, AND AN EVENT DATE OF THE SAME AS IMPLANT DATE IN 2003. UPDATE 08/12/08: DIAGNOSTIC AND OPERATIVE ARTHROSCOPY OF RIGHT SHOULDER SUTURE CAPSULAR RECONSTRUCTION; PAIN PUMP PLACEMENT INTO SHOULDER JOINT (300CC IN PAIN PUMP). IN 2004, DIAGNOSTIC AND OPERATIVE ARTHROSCOPIY OF RIGHT SHOULDER WAS PERFORMED WITH ARTHROSCOPIC CHONDRAL LOOSE BODY REMOVAL, HUMERAL HEAD CHONDROPLASTY, ANTERIOR AND POSTERIOR CAPSULE RELEASE. REPORTED ARTHROSCOPIC SUBACROMIAL DECOMPRESSION INCLUDING ACROMIOPLASTY AND CORACOACROMIAL LIGAMENT RELEASE. PHYSICIAN'S FINDINGS INCLUDE MILD CHERRY RED SYNOVITIS THROUGHOUT JOINT. SEVERAL CHONDRAL LOOSE BODIES AND FRAGMENTS WERE REMOVED. HUMERAL HEAD HAD DIFFUSE GRADE 2, 3 AND PATCHES OF GRADE 4 LESIONS. IT WAS REPORTED IN LATE 2004, THAT THERE WAS SEVERE OSTEOARTHRITIS IN SHOULDER AT 17. IN 2005, THERE WAS RIGHT SHOULDER HEMIARTHROPLASTY.

    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 MARCAINE 0.5%| WITH EPINEPHRINE