BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1070686 · Received July 7, 2008

    Report

    Report Number
    2026095-2008-00082
    Event Type
    Other
    Date Received
    July 7, 2008
    Report Date
    June 4, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE INVOLVED IN THIS IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVAL. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE INFO PROVIDED INDICATED THAT THE PT DEVELOPED AN INFECTION AFTER THE USE OF THE ON-Q PUMP. ALL I-FLOW PRODUCTS ARE STERILIZED AND SEALED IN APPROPRIATE PACKAGING, TO BE OPENED ONLY IN A STERILE ENVIRONMENT BY INDIVIDUALS TRAINED IN STERILE PROCEDURE. PRIOR TO RELEASE, ALL PRODUCTION LOTS ARE SUBJECTED TO STRINGENT LABORATORY TESTING TO ASSURE STERILITY. WITH THE ASSUMPTION THAT THE DEVICE WAS PROPERLY HANDLED BY THE CLINICAL PERSONNEL ASSOCIATED WITH THE SURGERY, THE DEVICE WAS INTRODUCED TO THE SURGICAL SITE IN A STERILE CONDITION. ANY INFECTION COMPLICATION FOLLOWING THEREAFTER IS MOST LIKELY DUE TO OTHER POSTOPERATIVE FACTORS. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2-3 DAYS INTO INFUSION, SURGEON NOTICED REDNESS, SWELLING AND TENDERNESS ON PT. PT WAS GIVEN IV ANTIBIOTICS AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER INFUSION PUMP MEB I-FLOW CORP. PM028-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other