BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 3674324 · Received January 29, 2014

    Report

    Report Number
    2950347-2014-00006
    Event Type
    Injury
    Date Received
    January 29, 2014
    Date of Event
    October 5, 2013
    Report Date
    January 29, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: MOSAIQ VERSION 2.30.04. REPORT SOURCE: VOLUNTARY REPORT NO: (B)(4). TYPE OF REPORTABLE EVENT: PT'S OUTCOME AS A RESULT OF THE OVERDOSE IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED HIGHER DOSES OF CHEMOTHERAPY THAN PHYSICIAN INTENDED. PT'S OUTCOME AS A RESULT OF THE OVERDOSE IS UNK. BASED ON THE INFORMATION OBTAINED FROM THE CUSTOMER, IT WAS DETERMINED THAT PRODUCT WORKS AS DESIGNED AND INTENDED AND DID NOT CAUSE THE MISTREATMENT TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63097 MOSAIQ ONCOLOGY INFORMATION SYS IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other