BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN MANAGEMENT SYSTEM

    MDR report key: 329604 · Received April 28, 2001

    Report

    Report Number
    2026095-2001-00001
    Event Type
    Injury
    Date Received
    April 28, 2001
    Date of Event
    March 22, 2001
    Report Date
    April 26, 2001
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PLACED THE ON-Q PUMP DURING A GASTRECTOMY WITH ONE REGULAR CATHETER AND ONE SOAKER CATHETER. THE PUMP WAS INSTALLED FOLLOWING THE MANUFACTURERS INSTRUCTIONS. IN 2001, IT WAS REPORTED TO THE REP THAT THE PATIENT HAD DEVELOPED A VERY SERIOUS INFECTION THAT APPEARED TO HAVE ORIGINATED AT THE ON-Q POINT OF ENTRY. THE DEVICE HAD BEEN IN PLACE FOR ABOUT 4 DAYS. THE PATIENT DEVELOPED A SEVERE INFECTION AND DEHISENCE RESULTING IN EVISERATION. THE PATIENT HAD TO BE RE-OPERATED ON AGAIN AND IS CURRENTLY IN THE HOSPITAL WITH SERIOUS INFECTIONS. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PLACED THE ON-Q PUMP DURING A GASTRECTOMY WITH ONE REGULAR CATHETER AND ONE SOAKER CATHETER. THE PUMP WAS INSTALLED FOLLOWING THE MANUFACTURERS INSTRUCTIONS. IN 2001, IT WAS REPORTED TO THE REP THAT THE PATIENT HAD DEVELOPED A VERY SERIOUS INFECTION THAT APPEARED TO HAVE ORIGINATED AT THE ON-Q POINT OF ENTRY. THE DEVICE HAD BEEN IN PLACE FOR ABOUT 4 DAYS. THE PATIENT DEVELOPED A SEVERE INFECTION AND DEHISENCE RESULTING IN EVISERATION. THE PATIENT HAD TO BE RE-OPERATED ON AGAIN AND IS CURRENTLY IN THE HOSPITAL WITH SERIOUS INFECTIONS. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PLACED THE ON-Q PUMP DURING A GASTRECTOMY WITH ONE REGULAR CATHETER AND ONE SOAKER CATHETER. THE PUMP WAS INSTALLED FOLLOWING THE MANUFACTURERS INSTRUCTIONS. IN 2001, IT WAS REPORTED TO THE REP THAT THE PATIENT HAD DEVELOPED A VERY SERIOUS INFECTION THAT APPEARED TO HAVE ORIGINATED AT THE ON-Q POINT OF ENTRY. THE DEVICE HAD BEEN IN PLACE FOR ABOUT 4 DAYS. THE PATIENT DEVELOPED A SEVERE INFECTION AND DEHISENCE RESULTING IN EVISERATION. THE PATIENT HAD TO BE RE-OPERATED ON AGAIN AND IS CURRENTLY IN THE HOSPITAL WITH SERIOUS INFECTIONS. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19751 ON-Q PAIN MANAGEMENT SYSTEM PAIN MANAGEMENT INFUSION SYSTEM MEB I-FLOW CORP. * 994873

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| L| R