BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP

    MDR report key: 1147527 · Received September 3, 2008

    Report

    Report Number
    2026095-2008-00129
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY INFORMATION CONCERNING THE PUMP, PROCEDURE, OR OTHER PARTICULARS OF THE ALLEGED INCIDENT. WITHOUT THE ACTUAL PRODUCT, PART NUMBER, LOT NUMBER OR FURTHER DETAILS OF THE INCIDENT, AN ANALYSIS CANNOT BE CONDUCTED. 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 STATED THAT THE PATIENT CALLED THE I-FLOW CORP HOTLINE FROM HOME IN RESPIRATORY DISTRESS. PATIENT WAS TAKEN TO HOSPITAL AND STAYED OVERNIGHT TO HAVE BREATHING MONITORED. IT WAS STATED THAT THE PATIENT'S DIAPHRAGM WAS PARALYZED DUE TO A NERVE BLOCK AND HAD A PARTIAL LUNG COLLAPSE. PATIENT IS RECOVERING AT HOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention