BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN-Q PAIN PUMP

    MDR report key: 3810154 · Received April 30, 2014

    Report

    Report Number
    2026095-2014-00051
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 1, 2003
    Report Date
    April 9, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFO CONTAINED IN THIS REPORT IS A LEGAL CLAIM THAT WAS VERBALIZED TO I-FLOWS LEGAL COUNSEL. 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 THE THREAT OF A LEGAL CLAIM, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING OR THREATENED LITIGATION. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: NOT PROVIDED; FILL VOLUME: NOT PROVIDED; FLOW RATE: NOT PROVIDED; PROCEDURE: SLAP REPAIR SURGERY ON HIS LEFT (NON-DOMINANT) SHOULDER; CATHPLACE: INTRA-ARTICULAR PLACEMENT (GH JOINT); DATE OF SURGERY: (B)(6), 2003 (DAY NOT PROVIDED). AN ATTORNEY REPRESENTING A CLIENT VERBALLY MADE I-FLOW'S LEGAL COUNSEL AWARE OF A LEGAL CLAIM REGARDING A PT WHO UNDERWENT SHOULDER SURGERY IN (B)(6) 2003. IT WAS REPORTED THAT AN I-FLOW PUMP WAS PLACED IN THE PATIENT'S GH JOINT POST-OPERATIVELY. IN (B)(6) 2008, HE WAS DIAGNOSED WITH SEVERE AND ADVANCED OSTEOARTHRITIS WITH GLOBAL CARTILAGE LOSS ON BOTH THE GLENOID AND HUMERUS. THE PATIENT'S ATTORNEY CLAIMED THAT HE HAS MEDICAL RECORDS CONFIRMING PRODUCT IDENTIFICATION, INTRA-ARTICULAR PLACEMENT, AND A CHONDROLYSIS DIAGNOSIS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258666 IN-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other| R