BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RA1000

    MDR report key: 1980243 · Received January 31, 2011

    Report

    Report Number
    3004526608-2011-00001
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT AN EXAM NOTE FOR PATIENT A WAS ERRONEOUSLY ENTERED INTO THE EXAM NOTE FOR PATIENT B. AS A RESULT, PATIENT B UNDERWENT AN UNNECESSARY SURGERY FOR PLACEMENT OF AN INFERIOR VENA CAVA FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA1000 LLZ GE HEALTHCARE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other