BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1166304 · Received September 17, 2008

    Report

    Report Number
    2026095-2008-00134
    Event Type
    Other
    Date Received
    September 17, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 24, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, MODEL OR LOT NUMBER, 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

    IT WAS REPORTED THAT THE PATIENT'S CHEST GOT RED FROM SHOULDER TO WAIST AND WAS WARM TO THE TOUCH A FEW HOURS AFTER THE DRESSING WAS REMOVED BY THE PATIENT'S WIFE. THE PATIENT'S WIFE CALLED I-FLOW CORPORATION'S HOTLINE, AND THE CLINICAL NURSE ADVISED THE PATIENT TO CALL THE ANESTHESIOLOGIST. THE ANESTHESIOLOGIST ADVISED THE PATIENT TO DISCONTINUE THE PUMP.

    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 UNK Other