BEUDAMED
    FDA Adverse Event Other Summary report: N

    STELLANT SX INJECTOR

    MDR report key: 1669104 · Received April 20, 2010

    Report

    Report Number
    2520313-2010-00015
    Event Type
    Other
    Date Received
    April 20, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 20, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CHECK OUT OF THE INJECTOR BY MEDRAD SERVICE WAS PERFORMED. THE SYSTEM CHECKED OUT ACCORDING TO SPECIFICATIONS. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED TO THE CUSTOMER, BUT THEY INDICATED THAT APPLICATIONS TRAINING WAS NOT NEEDED. NO PRODUCT RETURNING.

    Description of Event or Problem · 1

    HOSPITAL REPORTED DURING A CT SCAN OF THE CHEST AND NECK AN AIR INJECTION OCCURRED. AIR WAS IDENTIFIED IN THE RIGHT VENTRICLE AND THE RIGHT PULMONARY. THERE WAS NO IMPACT ON THE PATIENT AT THAT TIME. THE FAMILY WAS INSTRUCTED THAT IF THE PATIENT EXPERIENCED SHORTNESS OF BREATH, TO RETURN TO THE HOSPITAL. THE PATIENT RETURNED AND WAS ADMITTED OVERNIGHT FOR OBSERVATION ONLY; NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT SX INJECTOR STELLANT SX INJECTOR DXT MEDRAD, INC. 3007300

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization