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Regulatory Notices
Vicon MX Hardware System Reference E-11
Section E. User Facility Information
Check One
User Facility
Importer
User Facility Number
User Facility Name
User Facility Address
Contact Person
Phone Number
Date User Facility became
aware of event
(mm/dd/yyyy)
Type of Report
Initial
Follow-up
#_____________
Date of This
Report
Approximate age of system
Event problem Codes
(refer to “MEDWATCH
Medical Device Reporting
Code Instructions”)
Report sent to FDA?
Yes ____________
(mm/dd/yyyy)
No
Report sent to
manufacturer?
Yes ____________
(mm/dd/yyyy)
No
MXhardware_Reference.book Page 11 Monday, April 30, 2007 1:56 PM
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