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Regulatory Notices

E-8 Vicon MX Hardware System Reference

Section B. Adverse Event or Product Problem

Identification of adverse event or product problem

(check all that apply)

 Adverse Event

 Product Use Error

 Product Problem (e.g. defects/malfunctions)

 Problem with Different Manufacturer of Same

System

Outcomes attributed to the adverse event

(check all that apply)

 Death: ________________________

(mm/dd/yyyy)

 Life-threatening injury or illness

 Hospitalization—initial or prolonged

 Required intervention to prevent permanent

impairment/damage (Devices)

 Disability or permanent damage

 Congenital Anomaly/Birth Defect

 Other Serious (Important Medical Events)

Date of Event

(mm/dd/yyyy)

Date of this report

(mm/dd/yyyy)

Describe event, problem or product use error

(include 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)

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