BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1071746 · Received July 9, 2008

    Report

    Report Number
    2026095-2008-00084
    Event Type
    Other
    Date Received
    July 9, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 10, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. NO SAMPLE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. A NEW, UNUSED SAMPLE WAS BEING SUBMITTED FOR EVALUATION, BUT HAS NOT BEEN RECEIVED. NO INFO WAS RECEIVED THAT INDICATED ANY MALFUNCTION OF THE PUMP. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. ALL I-FLOW PRODUCTS ARE STERILIZED AND SEALED IN APPROPRIATE PACKAGING, TO BE OPENED ONLY IN A STERILE ENVIRONMENT BY INDIVIDUALS TRAINED IN STERILE PROCEDURE. PRIOR TO RELEASE, ALL PRODUCTION LOTS ARE SUBJECTED TO STRINGENT LAB TESTING TO ASSURE STERILITY. WITH THE ASSUMPTION THAT THE DEVICE WAS PROPERLY HANDLED BY THE CLINICAL PERSONNEL ASSOCIATED WITH SURGERY, THE DEVICE WAS INTRODUCED TO THE SURGICAL SITE IN A STERILE CONDITION. ANY COMPLICATION FOLLOWING THEREAFTER, IS MOST LIKELY DUE TO OTHER POSTOPERATIVE FACTORS. 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

    PT REPORTED THAT THEY DEVELOPED AN INFECTION FROM THE DUAL PUMP IN ORTHOPAEDICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM025 7B2907

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other