BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QS DELIVERY SYSTEM

    MDR report key: 428294 · Received November 15, 2002

    Report

    Report Number
    2134280-2002-00005
    Event Type
    Injury
    Date Received
    November 15, 2002
    Date of Event
    October 5, 2002
    Report Date
    November 15, 2002
    Manufacturer
    SUB-Q, INC.
    Product Code
    KYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED TREATMENT WITH THE QS DELIVERY SYSTEM TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE FOLLOWING A CATHETERIZATION PROCEDURE. AFTER THE DELIVERY OF THE GELFOAM 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention