BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTION SYSTEM

    MDR report key: 1951835 · Received December 30, 2010

    Report

    Report Number
    2520313-2010-00042
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 30, 2010
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS DECLINED ADDITIONAL APPLICATIONS TRAINING AND A MEDRAD SYSTEM SERVICE CHECK OF THE INJECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EXTRAVASATION OCCURRED WHILE THE STELLANT INJECTOR WAS IN USE. THE PATIENT REPORTEDLY REQUIRED SURGERY. WE HAVE MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT, INCLUDING PATIENT INFORMATION AND DETAILS OF THE EVENT. RISK MANAGEMENT AT THE SITE HAS DECLINED TO PROVIDE ANY FURTHER INFORMATION. THEY STATED THAT THIS INCIDENT DIDN'T HAVE ANYTHING TO DO WITH THE INJECTOR.

    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 Required Intervention