Section H

Question 1

What is Section H?

Answer 1

SECTION H: DEVICE MANUFACTURERS ONLY

Question 2

What is Section H1?

Answer 2

H1: Type of Reportable Event

Question 3

What Section does H1: Type of Reportable Event correlate/populate with? And how?

Answer 3

H1 will correlate/populate with B1 [Type of Report].
- If H1= Serious Injury, B1= Adverse Event
- If H1= Malfunction, B1= Product Problem
- If B1= Adverse Event & Product, H1= Serious Injury

Question 4

In what scenario does a B2 selection populate into H1?

Answer 4

When “Death” is selected in B2: Outcomes Attributed to Adverse Event, then H1: Type of Reportable Event will auto-populate with the selection “Death”

Question 5

What is Section H2?

Answer 5

H2: If Follow-up, What Type?

Question 6

In what scenario is Section H2 filled in, and in what scenario is it left blank?

Answer 6

No selections are necessary [should be left blank] in H2 unless the report is a Supplemental/Follow-Up. Will be left blank on initial MDR’s

Question 7

What types of Supplemental/Follow-Up reports are there?

Answer 7

o Correction: Changes to previously submitted information [think addendum].
o Additional information: Information concerning the event that was not provided in the initial report because it was not known/available when the report was originally submitted.
o Response to FDA request: Additional information requested by FDA concerning the device/event.
o Device evaluation: Evaluation/analysis of device.

Question 8

What is Section H3?

Answer 8

H3: Device Evaluated by Manufacturer?

Question 9

What is Section H4?

Answer 9

H4: Device Manufacture Date

Question 10

What is Section H5?

Answer 10

H5: Labeled for Single Use?

Question 11

What is Section H7?

Answer 11

H7: If Remedial Action Initiated, Check Type

Question 12

What is Section H6?

Answer 12

H6: Adverse Event Problem

Question 13

What information goes in H6?

Answer 13

• Space has been left for the manufacturer to enter the applicable terms & codes from the codes manual [Annexes]
At least one code must be entered in each of the categories listed.

Question 14

Is there a minimum number of codes that need to be entered in H6? If so, how many?

Answer 14

At least one code must be entered in each of the listed categories.

Question 15

Regarding the Cause Investiagtions - Investigation Findings and the Cause Investigations - Investigation Conclusions, what codes should be entered even if the suspected device was not evaluated?

Answer 15

Cause Investigation - Investigation Findings: Code 3233 - Results Pending Completion of Investigation

Cause Investigation - Investigation Conclusions: Code 11 - Conclusion Not Yet Available