BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN II NC HEMOSTASIS VALVE

    MDR report key: 2991773 · Received March 6, 2013

    Report

    Report Number
    2134812-2013-00011
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    VASCULAR SOLUTIONS ZERUSA LIMITED
    Product Code
    DTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CLINICAL PROCEDURE WHILE USING THE GUARDIAN II NC, THE PATIENT SEIZURED ON THE OPERATING TABLE.

    Description of Event or Problem · 1

    DURING A CLINICAL PROCEDURE WHILE USING THE GUARDIAN II NC, THE PATIENT SEIZURED ON THE OPERATING TABLE. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94994 GUARDIAN II NC HEMOSTASIS VALVE HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8215 29836

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening