BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 3853464 · Received April 4, 2014

    Report

    Report Number
    2950347-2014-00015
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A CHANGE IS MADE TO A DRUG NAME, ONLY THE NAME OF THE DRUG IS CHANGED. THE FOLLOWING ASSOCIATED FIELDS WITH THE DRUG ARE NOT CHANGED: - ADMIN INSTRUCTIONS, ERX INSTRUCTIONS, QUANTITY AND UNITS, REFILLS, PRN. THERE WAS NO ACTUAL MISTREATMENT REPORTED AS A RESULT OF THIS ISSUE BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203565 MOSAIQ MOSAIQ ONCOLOGY INFORMATION SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1