BEUDAMED
    FDA Adverse Event Other Summary report: N

    EZEM PERCUPUMP CONTROL

    MDR report key: 261835 · Received February 9, 2000

    Report

    Report Number
    MW1018105
    Event Type
    Other
    Date Received
    February 9, 2000
    Date of Event
    December 27, 1999
    Report Date
    January 10, 2000
    Manufacturer
    EZ-EM
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A CT SCAN WITH CONTRAST GIVEN INTRAVENOUSLY. A 20 GAUGE IV CATHETER WAS PLACED INTO AN ANTECUBITAL VEIN. AN EZEM EXTRAVASATION DETECTOR WAS PLACED ABOVE THE INJECTION SITE. THE PT STATED THEY COULD FEEL CONTRAST INFUSING, BUT IT WAS NOT PAINFUL. APPROXIMATELY 45 SECS AFTER THE INJECTION BEGAN, THE PT COMPLAINED OF PAIN IN THE ANTECUBITAL SPACE USED. THE EDA DEVICE DID NOT DETECT AN EXTRAVASATION. ALARM DID NOT ACTIVATE. SWELLING WAS NOTED BY THE TECHNOLOGIST AND THE SCAN WAS STOPPED. THE PT WAS ELEVATED BY A RADIOLOGIST. THE RADIOLOGIST THEN REFERRED THE PT TO HIS PRIMARY PHYSICIAN. THE PRIMARY PHYSICIAN OBTAINED A PLASTIC SURGERY CONSULTATION. ONE DAY AFTER THE EXTRAVASATION, ICING AND ELEVATING THE EXTREMITY, THE SWELLING WAS MARKEDLY IMPROVED. NO FURTHER MEDICAL INTERVENTION ENSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZEM PERCUPUMP CONTROL POWER INJECTOR IZQ EZ-EM UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other