BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC VASCULAR

    MDR report key: 873998 · Received July 2, 2007

    Report

    Report Number
    9611343-2007-00052
    Event Type
    Malfunction
    Date Received
    July 2, 2007
    Report Date
    July 2, 2007
    Manufacturer
    GE MEDICAL SYSTEMS S.C.S.
    Product Code
    IZI
    PMA / PMN Number
    K945375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO PTS HAD DERMATITIS, DUE TO LONG TIME EXPOSURE TO X-RAYS DURING EP EXAMS. THIS REPORT WILL SERVE AS REPORT 2 OF 2. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC VASCULAR ADVANTX LC+ IZI GE MEDICAL SYSTEMS S.C.S. 2183000

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR