BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL II

    MDR report key: 481802 · Received September 3, 2003

    Report

    Report Number
    2134280-2003-00004
    Event Type
    Injury
    Date Received
    September 3, 2003
    Date of Event
    August 1, 2003
    Report Date
    September 3, 2003
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED WITH THE QUICKSEAL ARTERIAL CLOSURE SYSTEM IN 2003 TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE FOLLOWING A CATHETERIZATION PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A PSEUDOANEURYSM NEAR THE PUNCTURE SITE AND WAS TREATED WITH TWO (2) INJECTIONS OF THROMBIN FOR THE PSEUDOANEURYSM. THE PSEUDOANEURYSM WAS RESOLVED WIHOUT FURTHER COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSEAL II VASCULAR HEMOSTATIS DEVICE MGB SUB-Q, INC. NA 03D003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention