BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QS DELIVERY SYSTEM

    MDR report key: 409122 · Received August 2, 2002

    Report

    Report Number
    2134280-2002-00002
    Event Type
    Injury
    Date Received
    August 2, 2002
    Date of Event
    May 16, 2002
    Report Date
    August 2, 2002
    Manufacturer
    SUB-Q INC.
    Product Code
    KYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ORIGINALLY TREATED FOR STENOSIS OF THE RIGHT CAROTID ARTERY AND REC'D TREATMENT WITH THE QS DELIVERY SYSTEM TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE FOLLOWING THE INTERVENTIONAL TREATMENT FOR STENOSIS IN THE CAROTID ARTERY. MINUTES FOLLOWING THE DELIVERY OF THE GEL FOAM HEMOSTATIC SPONGE, THE PT EXHIBITED NO DISTAL PULSE IN THE TREATED LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QS DELIVERY SYSTEM IRRIGATION SYRINGE KIT KYZ SUB-Q INC. QAK5 840424J

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention