BEUDAMED
    FDA Adverse Event Summary report: N

    GE HEALTHCARE OMNIPAQUE

    MDR report key: 811349 · Received January 31, 2007

    Report

    Report Number
    MW4004271
    Date Received
    January 31, 2007
    Date of Event
    November 2, 2006
    Report Date
    November 7, 2006
    Manufacturer
    GE HEALTHCARE
    Product Code
    KTA
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN CALLED TO REPORT POSSIBLY CONTAMINATED INGESTABLE. PRODUCT WAS USED ON PT AND ON THE SAME NIGHT THE PT RETURNED TO THE HOSP AND WAS DIAGNOSED WITH BACTERIAL MENINGITIS. DR CALLED THE DRUG COMPANY WHO STATED THAT THERE HAD BEEN PROBLEMS WITH OMNIPAQE 240.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE OMNIPAQUE * KTA GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *