BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN MANAGEMENT SYSTEM

    MDR report key: 329592 · Received April 28, 2001

    Report

    Report Number
    2026095-2001-00004
    Event Type
    Injury
    Date Received
    April 28, 2001
    Date of Event
    March 27, 2001
    Report Date
    April 27, 2001
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ESS WAS NOTIFIED BY THE OR DIRECTOR OF AN ADVERSE EVENT POSSIBLY RELATED TO THE ON-Q PUMP. IT WAS REPORTED THAT THE PATIENT HAD A COLECTOMY IN 2000. THREE TO FOUR DAYS POST-OPERATIVELY, IT WS REPORTED THE PATIENT'S INCISION WAS DEVELOPING NECROSIS. IT IS ALLEGED THAT THE PATIENT IS MORBIDLY OBESES, MAYBE DIABETIC, AND THE EPINEPHRINE WAS PRESENT IN THE ON-Q PUMP. NO FURTHER DATA CAN BE COMFIRMED AT THIS TIME. IT IS UNKNOWN WHETHER THE DEVICE IS AVAILABLE OR IF IT WILL BE MADE AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    ESS WAS NOTIFIED BY THE OR DIRECTOR OF AN ADVERSE EVENT POSSIBLY RELATED TO THE ON-Q PUMP. IT WAS REPORTED THAT THE PATIENT HAD A COLECTOMY IN 2000. THREE TO FOUR DAYS POST-OPERATIVELY, IT WAS REPORTED THE PATIENT'S INCISION WAS DEVELOPING NECROSIS. IT IS ALLEGED THAT THE PATIENT IS MORBIDLY OBESES, MAYBE DIABETIC, AND THE EPINEPHRINE WAS PRESENT IN THE ON-Q PUMP. NO FURTHER DATA CAN BE COMFIRMED AT THIS TIME. IT IS UNKNOWN WHETHER THE DEVICE IS AVAILABLE OR IF IT WILL BE MADE AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    ESS WAS NOTIFIED BY THE OR DIRECTOR OF AN ADVERSE EVENT POSSIBLY RELATED TO THE ON-Q PUMP. IT WAS REPORTED THAT THE PATIENT HAD A COLECTOMY IN 2000. THREE TO FOUR DAYS POST-OPERATIVELY, IT WAS REPORTED THE PATIENT'S INCISION WAS DEVELOPING NECROSIS. IT IS ALLEGED THAT THE PATIENT IS MORBIDLY OBESES, MAYBE DIABETIC, AND THE EPINEPHRINE WAS PRESENT IN THE ON-Q PUMP. NO FURTHER DATA CAN BE COMFIRMED AT THIS TIME. IT IS UNKNOWN WHETHER THE DEVICE IS AVAILABLE OR IF IT WILL BE MADE AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19672 ON-Q PAIN MANAGEMENT SYSTEM PAIN MANAGEMENT INFUSION SYSTEM MEB I-FLOW CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization