BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDX VCC

    MDR report key: 598602 · Received April 29, 2005

    Report

    Report Number
    2918630-2005-00003
    Event Type
    Injury
    Date Received
    April 29, 2005
    Date of Event
    March 24, 2005
    Report Date
    April 22, 2005
    Manufacturer
    CARL ZEISS MEDITEC INC
    Product Code
    JXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PT EXPERIENCED A FACE RASH APPROX. 12-14 HOURS FOLLOWING DIAGNOSIS WITH THE SUBJECT DEVICE. THE MANUFACTURER CONTACTED THE USER FACILITY FOR ADD'L INFO. THE USER FACILITY STATED THAT THE PT WAS TREATED FOR REPORTED SWELLING, REDNESS, DISCOMFORT IN THEIR EYES AND MINOR VISION LOSS. IN THE PT'S RASH WAS 90% CLEAR WITH THEIR VISION BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDX VCC NERVE FIBER ANALYZER JXE CARL ZEISS MEDITEC INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention