BEUDAMED
    FDA Adverse Event Summary report: N

    LIGHTSPEED RT 16 SCANNER

    MDR report key: 1241690 · Received October 31, 2008

    Report

    Report Number
    1241690
    Date Received
    October 31, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 31, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED THE RADIOLOGY DEPARTMENT TO REPORT THAT EVER SINCE SHE HAD HER CT BRAIN SCAN, HER EYES HAVE BEEN RED AND DRY. THE PATIENT WORE HER CONTACTS DURING THE CT TEST. THE PATIENT WAS REFERRED TO HER PRIMARY CARE PHYSICIAN FOR FOLLOW UP. THERE WAS NO COMPLAINT OR CONCERNS WHEN SHE HAD HER CT BRAIN SCAN PERFORMED LAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED RT 16 SCANNER CT SCANNER JAK GE MEDICAL SYSTEMS, LLC LIGHT SPEED 16 SCANNER *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HORMONAL REPLACEMENT THERAPY| OTHER| HORMONAL REPLACEMENT THERAPY| OTHER