BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RADIAL SHEATH INTRODUCER SET

    MDR report key: 1130462 · Received August 20, 2008

    Report

    Report Number
    1820334-2008-00454
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    July 25, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE COMPLAINT DEVICE NOR THE LOT NUMBER WAS PROVIDED TO ASSIST IN OUR INVESTIGATION. HOWEVER, WE ARE AWARE OF THE POTENTIAL FOR OCCURENCE AND CAN ADVISE THAT THIS PRODUCT LINE IS SUPPLIED WITH AN INSTRUCTIONS FOR USE WHICH STATES THE FOLLOWING: "POSSIBLE ALLERGIC REACTIONS SHOULD ALWAYS BE CONSIDERED. A STERILE INFLAMMATORY RESPONSE POSSIBLY ASSOCIATED WITH THE USE OF THE PRODUCT IN CONJUNCTION WITH LATEX AND POWDERED NON-LATEX BASED GLOVES HAS BEEN REPORTED WITH THE USE OF THIS DEVICE." WE WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    THERE WAS A DEVELOPMENT OF GRANULOMA AT THE RADIAL PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RADIAL SHEATH INTRODUCER SET DYB INTRODUCER CATHETER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other