BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 930371 · Received October 18, 2007

    Report

    Report Number
    2026095-2007-00056
    Event Type
    Other
    Date Received
    October 18, 2007
    Report Date
    September 21, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT WAS REPORTED AVAILABLE, BUT HAS NOT BEEN RETURNED TO I-FLOW CORPORATION FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN INFECTION AFTER SURGERY. THE SURGERY WENT FINE (C-SECTION TO REMOVE CYST). PATIENT WAS GIVEN MEDICATION FOR INFECTION AND IS IMPROVING AND DOING FINE. THIS WAS THE FIRST TIME THE SURGEON HAD USED THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. NA 612935

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention