Section E

Question 1

What is Section E1?

Answer 1

Section E1: [Initial] Reporter Name and Address

Question 2

What information goes in Section E1?

Answer 2

• the name, mailing address, phone number, and email address of the person who initially reported the adverse event to the user facility, manufacturer, or importer, and who can be contacted to provide information on the event if follow-up is necessary.
• for medical device reporting by user facilities, this person may or may not be the designated medical device reporting (MDR) contact.

Question 3

What is Section E2?

Answer 3

E2: Health Professional

Question 4

What information goes in Section E2?

Answer 4

Indicate whether the initial reporter is a health professional (e.g., physician, pharmacist, nurse, etc.) or not. If not a health professional, complete block E3 [Occupation] by filling in NA.

Question 5

What is Section E3?

Answer 5

E3: Occupation

Question 6

What information goes in Section E3?

Answer 6

• Indicate the initial reporter’s occupation (particularly type of health professional e.g. physician assistant, and include specialty e.g. cardiology, if appropriate.
• if not a health professional, complete block E3 by filling in NA.

Question 7

What is Section E4?

Answer 7

E4: Initial Reporter Also Sent Report to FDA

Question 8

What should be entered in E3 [Occupation] if in E2 [Healthcare Professional] the answer is “No?”

Answer 8

If the initial reporter’s not a healthcare professional, as indicated in E2, then “NA” should be entered in E3.

Question 9

What goes in section E4?

Answer 9

Indicate whether the initial reporter also notified or submitted a copy of this report to FDA.