BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 763458 · Received September 14, 2006

    Report

    Report Number
    2026095-2006-00063
    Event Type
    Other
    Date Received
    September 14, 2006
    Date of Event
    August 14, 2006
    Report Date
    September 11, 2006
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT IS NOT AVAILABLE FOR EVAL; THEREFORE, OUR RESULTS AND CONCLUSION ARE BASED ON THE INFO THAT WAS GIVEN TO I-FLOW BY THE INITIAL REPORTER. ACCORDING TO THE CENTER FOR DISEASE CONTROL, POSTOPERATIVE SURGICAL SITE INFECTION VARIES FROM SURGEON TO SURGEON, HOSP TO HOSP, PROCEDURE TO PROCEDURE, AND PT TO PT. THE ATTACHED CLINICAL STUDY PERFORMED ON THE ON-Q PAIN RELIEF SYSTEM FOUND THAT THE RATE OF INFECTION WITH A CONTINUOUS PUMP WAS EQUAL TO OR LESS THAN THE PUBLISHED RATE. OUR DEVICES ARE MANUFACTURED AS BEING STERILE. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    SIX (6) DAYS POST C-SECTION PROCEDURE - SYSMTOMS OF REDNESS, SWELLING, FEVER AND BODY ACHES AT THE ON-Q SITE RADIATING TOWARD THE INCISION WERE OBSERVED BY THE PT AT HOME. THE PT REC'D KEFLEX FOR SEVEN (7) DAYS TO TREAT THE INFECTION. THE PT'S STATUS IS UNKNOWN; HOWEVER, IS STILL BEING TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM013 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other