BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLANT DUAL INJECTION SYSTEM

    MDR report key: 2713526 · Received August 22, 2012

    Report

    Report Number
    2520313-2012-00023
    Event Type
    Death
    Date Received
    August 22, 2012
    Date of Event
    July 3, 2012
    Report Date
    July 25, 2012
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN ADDITIONAL INFORMATION; HOWEVER THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. A SYSTEM SERVICE CHECK OF THE STELLANT INJECTOR HAS BEEN OFFERED TO THE SITE. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE SITE DECLINED. BASED ON THE LIMITED INFORMATION REPORTED, WE ARE UNABLE TO DETERMINE IF THE STELLANT INJECTOR CONTRIBUTED TO THE ALLEGED EVENT. IN THE EVENT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A MEDWATCH WAS RECEIVED FROM THE FDA ON (B)(6) 2012. A PATIENT WITH AN ADMITTING DIAGNOSIS OF ABDOMINAL PAIN, VOMITING, DIARRHEA, AND FEVER WAS UNDERGOING A CT SCAN. POST PROCEDURE, THE PATIENT COMPLAINED OF HER HEART RACING AND DIFFICULTY BREATHING. THE PATIENT DID NOT EXPERIENCE ANY THROAT TIGHTNESS, SWELLING, OR HIVES. O2 SATURATION LEVEL REMAINED AT 100%. THE REPORT STATES "UNSURE IF REACTION TO CONTRAST DYE OR NOT." ULTIMATELY, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT DUAL INJECTION SYSTEM CT INJECTION SYSTEM DXT MEDRAD 3010432

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death