BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1062396 · Received June 18, 2008

    Report

    Report Number
    2026095-2008-00070
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    March 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. THE INFO PROVIDED BY THE SURGEON INDICATED THAT THE PT HAD EXPERIENCED "LIVER PROBLEMS". THE ACTUAL SURGICAL PROCEDURE, DATE OF SURGERY, DATE OF LIVER DIAGNOSIS, AND TYPE OF MEDICATIONS USED WERE NOT PROVIDED. THE PHYSICIAN DID PROVIDE INFO THAT THE CONDITION "MAY HAVE BEEN A RESULT OF ANTI-INFLAMMATORY DRUG USE." THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED. THE PT HAD RESUMED NORMAL ACTIVITIES. 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 DEVELOPED LIVER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORPORATION PM012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other