BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA

    MDR report key: 201201 · Received December 9, 1998

    Report

    Report Number
    2432460-1998-00029
    Event Type
    Other
    Date Received
    December 9, 1998
    Date of Event
    November 5, 1998
    Report Date
    November 9, 1998
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR EXAM. THE EDA PATCH WAS NOT USED AS THE PTS SKIN WAS VERY THIN AND EVEN TAPE REMOVED THE SKIN. AN EXTRAVASATION, ESTIMATED TO BE APPROX 60-80 CC'S OCCURRED. A PLASTIC SURGEON WAS CALLED AND NO FURTHER MEDICAL INTERVENTION OTHER THAN ELEVATING THE ARM AND APPLYING HOT PACKS WAS REQUIRED. PT WAS CHECKED AGAIN BY THE RADIOLOGIST THE FOLLOWING DAY AND WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA CT INJECTOR W/EXTRAVASATION ACCESSORY FIH E-Z-EM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other CONTRAST.| 20 GAUGE ANGIOCATH, OMNIPAQUE 300 NON-IONIC