BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q BY I-FLOW

    MDR report key: 1581247 · Received January 13, 2010

    Report

    Report Number
    MW5014374
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 10, 2009
    Report Date
    December 31, 2009
    Manufacturer
    I FLOW
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO ON-Q CATHETERS INSERTED ON (B) (6) 2009 FOR PAIN CONTROL. ONE 5 INCH AND ONE 7.5 INCH CATHETER. ON (B) (6) 2009, TO OR FOR PERFORATED BOWEL. SURGEON NOTED CATHETER IN BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q BY I-FLOW ON-Q SOAKER CATHETER (5 INCH AND 7.5 INCH) BSO I FLOW PM020-A
    2 ON-Q BY I-FLOW ON-Q TUNNELER DYB I-FLOW PM050-A T16X12

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R