BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1345043 · Received March 10, 2009

    Report

    Report Number
    2026095-2009-00049
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    February 8, 2009
    Report Date
    February 10, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE DEVICE IS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE, LOT NUMBER, OR DETAILS OF THE INCIDENT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. 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 REOPEN THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DEVELOPED AN INFECTION AFTER A C-SECTION AT THE CATHETER SITE WHILE USING AN ON-Q PUMP. PT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER BSO I-FLOW CORP. PMO25-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other