BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTION SYSTEM

    MDR report key: 1911334 · Received November 24, 2010

    Report

    Report Number
    2520313-2010-00040
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK OF THE STELLANT INJECTOR VERIFIED THE INJECTOR WAS OPERATING WITHIN MEDRAD SPECIFICATIONS. ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED ON (B)(4), 2010.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PT WITH AN ADMITTING DIAGNOSIS OF PARASTHESIA IN ALL EXTREMITIES WAS SCHEDULED FOR A SIX MONTH F/U CT SCAN OF THE HEAD. DURING THE CT SCAN, THE TECHNOLOGIST NOTED THAT NO CONTRAST WAS VISUALIZED ON THE IMAGES. APPROX 80 MLS OF CONTRAST HAD EXTRAVASATED. POST-PROCEDURE, THE PT WAS SENT TO THE EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH COMPARTMENTAL SYNDROME REQUIRING SURGICAL REPAIR. ACCORDING TO RISK MANAGEMENT AT THE SITE, THE PT WAS SEEN BY HER PHYSICIAN ON (B)(6), 2010 AND IS REPORTEDLY RECOVERING AND SHOULD CONTINUE TO IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT DUAL CT INJECTION SYSTEM CT INJECTION SYSTEM DXT MEDRAD 3007301

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R