BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD CT INJECTOR

    MDR report key: 1081664 · Received July 24, 2008

    Report

    Report Number
    2520313-2008-00014
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD SERVICE REPRESENTATIVE CHECKED THE INJECTOR AND NO PROBLEMS WERE FOUND WITH THE UNIT. A MEDRAD CLINICAL SUPPORT SPECIALIST WAS IN CONTACT WITH THE SITE REGARDING THE INCIDENT AND ANY QUESTIONS THAT THEY HAD WERE ADDRESSED. THE CUSTOMER DECLINED ADDITIONAL ON-SITE APPLICATIONS TRAINING.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT THE PATIENT WAS SCHEDULED FOR A CHEST CT SCAN. THE PATIENT ARRIVED TO THE UNIT WITH AN IV THAT WAS PLACED BY A FLOOR NURSE ON THE PLANTER AREA OF THE LEFT WRIST. DURING THE CT SCAN, NO CONTRAST WAS SEEN ON THE IMAGES. WHEN THE STAFF WENT INTO THE ROOM, THE PATIENT SAID THAT HER ARM FELT TIGHT AND SHE WAS IN PAIN. THE PATIENT'S LEFT FOREARM, WRIST, AND FINGERS WERE SWOLLEN DUE TO AN EXTRAVASATION. THE TECHNOLOGIST APPLIED ICE PACKS AND CALLED FOR A NURSE AND A RADIOLOGIST. AFTER ABOUT TEN MINUTES OF ICE APPLICATION, THE FINGERS WERE MOVABLE AND THE SWELLING HAD REDUCED. TWO DAYS LATER, IN 2008, THE PATIENT REQUIRED A FASCIOTOMY ON HER LEFT FOREARM. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD CT INJECTOR CT INJECTOR DXT MEDRAD, INC. SCT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention