BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLOSUREFAST CATHETER, 7F, 60CM

    MDR report key: 1975715 · Received January 25, 2011

    Report

    Report Number
    2953189-2011-00003
    Event Type
    Other
    Date Received
    January 25, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 14, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN ELECTROSURGICAL DEVICE. THE CUSTOMER REPORTS THAT AT THE THREE DAY F/U APPOINTMENT THEY NOTICED A THROMBUS EXTENSION INTO THE SFJ. THE PT WAS SENT FOR ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSUREFAST CATHETER, 7F, 60CM ELECTROSURGICAL DEVICE GEI COVIDIEN CF7-7-60 523238

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other