BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK CLOSUREFAST CATHETER

    MDR report key: 1790592 · Received August 2, 2010

    Report

    Report Number
    2953189-2010-00009
    Event Type
    Other
    Date Received
    August 2, 2010
    Date of Event
    October 1, 2008
    Report Date
    July 12, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A CLOSURE FAST CATHETER. THE CUSTOMER REPORTS THAT SHE HAD CLOSURE PROCEDURE ON HER LEFT LEG IN (B)(6) 2008. RECENTLY, THE CUSTOMER WAS EXPERIENCING PAIN IN THE LEG WITH FEELINGS OF LEG WEIGHTS. CUSTOMER HAD ULTRASOUND OF THE LEG WHICH SHOWED THAT THIS PROCEDURE MAY NOT HAVE CLOSED THE VEIN FULLY. SHE STATES THIS FAILED PROCEDURE RESULTED IN PAIN IN THE LEG FOR WHICH SHE IS USING A LIDODERM 5% PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CLOSUREFAST CATHETER ELECTROSURGICAL DEVICE GEI COVIDIEN UNK CLOSURE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK