BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QN-Q SILVERSOAKER

    MDR report key: 1385959 · Received May 12, 2009

    Report

    Report Number
    2026095-2009-00110
    Event Type
    Injury
    Date Received
    May 12, 2009
    Date of Event
    April 14, 2009
    Report Date
    April 14, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. NO SAMPLE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE INFORMATION RECEIVED CONFIRMED NO MALFUNCTION OF THE DEVICE. TECHNIQUE USED FOR THE SURGERY CAUSED THE EVENT. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    FOLLOWING A CABG AND HERNIA REPAIR OPERATION, THE SALES REP WAS INFORMED THAT IT APPEARS THE BOWEL WAS PUNCTURED DURING THE SURGERY BY THE INTRODUCER NEEDLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention