BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL SURESHOT

    MDR report key: 539149 · Received August 11, 2004

    Report

    Report Number
    2134280-2004-00002
    Event Type
    Injury
    Date Received
    August 11, 2004
    Date of Event
    July 15, 2004
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED TREATMENT WITH QUICKSEAL SURESHOT CLOSURE DEVICE TO ACHIEVE HEMOSTATIS AT THE ARTERIAL PUNCTURE SITE FOLLOWING AN INTERVENTIONAL PROCEDURE. FOLLOWING THE DELIVERY OF THE HEMOSTATIC SPONGE, THE PT EXHIBITED NO DISTAL PULSE IN THE TREATED LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSEAL SURESHOT VASCULAR HEMOSTASIS DEVICE MGB SUB-Q, INC. NA 04F005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention