BEUDAMED
    FDA Adverse Event Summary report: N

    MARK V PROVIS

    MDR report key: 1419727 · Received July 21, 2009

    Report

    Report Number
    1419727
    Date Received
    July 21, 2009
    Date of Event
    June 29, 2009
    Report Date
    July 21, 2009
    Manufacturer
    MEDRAD, INC.
    Product Code
    IZQ
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TESTED PRIOR TO ADMINISTRATION. IV LEFT FOREARM SITE, INFILTRATION OF 20 CC GAD AND 46 CC SALINE.THE HOSPITAL'S STANDARD PROTOCOL ALWAYS INCLUDES TESTING THE LINE FOR PATENCY USING A SALINE FILLED SYRINGE, PRIOR TO POWER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK V PROVIS POWER INJECTOR IZQ MEDRAD, INC. SPECTRIS MR *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR