BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RADIAL INTRODUCER

    MDR report key: 1600673 · Received February 12, 2010

    Report

    Report Number
    1820334-2010-00067
    Event Type
    Injury
    Date Received
    February 12, 2010
    Report Date
    January 13, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION - UNK AS LOT IS UNK. (B) (4). THE PROVIDED INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "POSSIBLE ALLERGIC REACTIONS OR ACCESS SITE INFECTION SHOULD ALWAYS BE CONSIDERED. A STERILE INFLAMMATORY RESPONSE POSSIBLY ASSOCIATED WITH THE USE OF THE PRODUCT IN CONJUNCTION WITH LATEX AND POWERED NON-LATEX BASED GLOVES HAVE BEEN REPORTED WITH THE USE OF THIS PRODUCT." UPON COMPLETION OF REVIEW AND/OR TESTING, QAC LAB WILL DETERMINE IF LOAD IS ACCEPTABLE FOR RELEASE. PRODUCT WAS NOT RETURNED AND NO EVIDENCE EXISTS TO CONTRADICT THE COMPLAINT AS REPORTED; HOWEVER, ORDER HISTORY FOR CUSTOMER SHOWS IN 2008 AND 2009 ORDERS FOR FLEXOR CHECK-FLO INTRODUCER SETS. THE INVESTIGATION OF THIS COMPLAINT IS BASED ON THIS CUSTOMER ORDER INFO. WE ARE CONTINUING TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN INFLAMMATORY RESPONSE AT THE INSERTION SITE. PT OUTCOME IS UNK AS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RADIAL INTRODUCER NONE DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention