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Regulatory Notices

E-4 Vicon MX Hardware System Reference

Section C. Description of Event or Problem

Parameter Date

Date of Event MM/DD/YYYY

Date of report by initial reporter MM/DD/YYYY

Description of event or problem, including a

discussion of how the device was involved, nature

of the problem, patient follow-up or required

treatment and any environmental conditions that

may have influenced the event

Description of relevant tests including dates and

laboratory data

Description of the relevant history including

pre-existing medical conditions

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