BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL ARTERIAL CLOSURE SYSTEM

    MDR report key: 416658 · Received September 12, 2002

    Report

    Report Number
    2134280-2002-00003
    Event Type
    Injury
    Date Received
    September 12, 2002
    Date of Event
    August 13, 2002
    Report Date
    September 12, 2002
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED TREATMENT WITH THE QUICKSEAL ARTERIAL CLOSURE SYSTEM TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE FOLLOWING A DIAGNOSTIC CATHERIZATION PROCEDURE. SIX DAYS AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND AN INFECTION WAS OBSERVED NEAR THE SKIN SURFACE IN THE GROIN. FOLLOW-UP TREATMENT INCLUDED DRAINING THE INFECTED SITE AND THE ADMINISTRATION OF IV ANTIBIOTICS. NO FURTHER RELATED EVENTS WERE EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSEAL ARTERIAL CLOSURE SYSTEM VASCULAR HEMOSTASIS DEVICE MGB SUB-Q, INC. 38944-0 901814J

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention