BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q

    MDR report key: 540192 · Received August 19, 2004

    Report

    Report Number
    2026095-2004-00025
    Event Type
    Injury
    Date Received
    August 19, 2004
    Report Date
    July 20, 2004
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED PAIN RELIEF FROM AN ON-Q INFUSION PUMP FOLLOWING A HERNIA OPERATION. THE INFUSION PERIOD LASTED APPROXIMATELY 2-1/2 DAYS; AFTER WHICH, THE PT DID NOT REMOVE THE CATHETER PROVIDED WITH THE PUMP FOR 3 ADDITIONAL DAYS. SUBSEQUENTLY, THE PT DEVELOPED AN INFECTION. INFECTIONS CAN AND DO OCCUR IN SOME CASES REGARDLESS OF THE PAIN RELIEF METHOD USED (PLACEBO-CONTROLLED TRIAL OF LOCAL ANESTHETIC INFUSION IN DAY-CASE HERNIA REPAIR - BRITISH JOURNAL OF SURGERY 1998;85;797-799). ALTHOUGH THE DIRECT CAUSE OF THE INFECTION IS NOT EVIDENT, FACTORS, UNRELATED TO THE PERFORMANCE OF THE PRODUCT, I.E. CATHETER LEFT IN PT, MAY HAVE CONTRIBUTED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q INFUSION PUMP MEB I-FLOW CORP. PM012 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention