BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QS DELIVERY SYSTEM

    MDR report key: 402396 · Received June 28, 2002

    Report

    Report Number
    2134280-2002-00001
    Event Type
    Injury
    Date Received
    June 28, 2002
    Date of Event
    May 25, 2002
    Report Date
    June 26, 2002
    Manufacturer
    SUB-Q, INC.
    Product Code
    KYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ORIGINALLY TREATED FOR A GI BLEED AND RECEIVED TREATMENT WITH THE QS DELIVERY SYSTEM LATE IN THE EVENING TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE FOLLOWING THE INTERVENTIONAL TREATMENT FOR THE GI BLEED. MINUTES FOLLOWING THE DELIVERY OF THE GELFOAM HEMOSTATIC SPONGE, THE PAITENT 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 R860524J

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention