Section B

Question 1

What is B1?

Answer 1

Report Type

Question 2

What types of reports are there?

Answer 2

• Adverse Event
• Product Problem [defects or malfunctions]
• Both: product problem resulting in an adverse event.

Question 3

Which section in the report will section B1 correlate/populate with? How?

Answer 3

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

Question 4

What is Section B2?

Answer 4

Outcomes Attributed to the Adverse Event.

Question 5

When is the “Product Problem” category selected in B1: Report Type?

Answer 5

This category is selected when the device being reported has a defect or malfunction that could lead to a death or serious injury if it were to reoccur, but didn’t harm the PT.

Question 6

What is section B3?

Answer 6

Date of the Event

Question 7

What goes in Section B4?

Answer 7

Date of the Report: the date the report is submitted to the FDA .

Question 8

What is Section B5?

Answer 8

Describe the Event or Problem

Question 9

When will Section B2 be left without a single box selected? Why?

Answer 9

This section will be left blank unless Adverse Event is selected in B1. Section B2 is for the outcomes attributed to the Adverse Event.

Question 10

What is Section B6?

Answer 10

B6: Relevant Test/Laboratory Data, Including Dates

Question 11

What INformation goes in B6?

Answer 11

Include:
- Any relevant negative test and laboratory findings, to most completely convey how the medical work-up/assessment led to a strong suspicion of medical-product-induced disease as etiology for clinical status,
as other DDX considerations were being eliminated.
- Relevant baseline labs
- All lab data used in DX the event.
- Engineering analyses of devices
If available, include:
- pre/post-event medication levels and dates
- Synopses of any relevant autopsy, pathology, engineering, or lab reports.

Question 12

What is B7?

Answer 12

B7: Other Relevant History, Including Preexisting Medical Conditions:

Question 13

What information goes in B7?

Answer 13

PMHX [Ex: HTN, DM, RF, PE]
Significant history
– Allergies
– Pregnancy history
– Smoking and alcohol use
– Drug abuse, etc.

Question 14

What goes in Section B5 for an Adverse Event?

Answer 14

For an adverse event:
- Describe the event in detail using the reporter’s own words,
- include a description of what happened and
- a summary of all relevant clinical information:
I. clinical status prior to the event
II. S/S
III. DDX for the event in question
IV. clinical course, treatment, outcome, etc.
- Information as to any environmental conditions that may have influenced the event should be included, particularly when (but not exclusive to) reporting about a device.

Question 15

What goes in Section B5 for a Product Problem?

Answer 15

For a product problem:
- A detailed description of the problem, whether that be a quality or performance issue, or a safety concern.
- If available or known:
I. the results of any evaluation of a malfunctioning device and,
II. any relevant maintenance/service information should be included in this section.

Question 16

What goes in Section B5 for HCT/P’s?

Answer 16

Provide information on the type of surgical procedure and anatomical site of implantation, and the date of onset of symptoms. [Think of writting narrative for IV procedure]

Question 17

When a newborn baby is found to have a congenital anomaly, what is considered the onset [or Date of Event] of the Adverse Event?

Answer 17

When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth of the child.

Question 18

When a fetus is aborted because of a congenital anomaly, or is miscarried, what is considered the onset date of the Adverse Event?

Answer 18

When a fetus is aborted because of a congenital anomaly or is miscarried (spontaneous abortion), the event onset date is the date pregnancy is terminated.

Question 19

If information is available as to the time during pregnancy when exposure occurred, where should this be input in the report?

Answer 19

If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5.

Question 20

In B5: Describe the Event or Problem, what should be avoided when writing your narrative?

Answer 20

• capitalization of procedures.
• Acronyms; If you utilized an acronyms, spell out what it stands for the first time it’s used.
• Avoid Product ID’s, and utilize the common device name, or simply refer to the product in question as “device”.
• DO NOT contain any personal identifiable information (PII) or proprietary information, if PII or proprietary information is critical to understand the event, that information should be included in B6 Related Test/Laboratory Data or B7 Other Medical History, including Preexisting Medical Conditions.

Question 21

What is Section B?

Answer 21

Adverse Event or Product Problem