Section B Flashcards
What is B1?
Report Type
What types of reports are there?
- Adverse Event
- Product Problem [defects or malfunctions]
- Both: product problem resulting in an adverse event.
Which section in the report will section B1 correlate/populate with? How?
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
What is Section B2?
Outcomes Attributed to the Adverse Event.
When is the “Product Problem” category selected in B1: Report Type?
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.
What is section B3?
Date of the Event
What goes in Section B4?
Date of the Report: the date the report is submitted to the FDA .
What is Section B5?
Describe the Event or Problem
When will Section B2 be left without a single box selected? Why?
This section will be left blank unless Adverse Event is selected in B1. Section B2 is for the outcomes attributed to the Adverse Event.
What is Section B6?
B6: Relevant Test/Laboratory Data, Including Dates
What INformation goes in B6?
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.
What is B7?
B7: Other Relevant History, Including Preexisting Medical Conditions:
What information goes in B7?
PMHX [Ex: HTN, DM, RF, PE]
Significant history
– Allergies
– Pregnancy history
– Smoking and alcohol use
– Drug abuse, etc.
What goes in Section B5 for an Adverse Event?
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.
What goes in Section B5 for a Product Problem?
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.
What goes in Section B5 for HCT/P’s?
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]
When a newborn baby is found to have a congenital anomaly, what is considered the onset [or Date of Event] of the Adverse Event?
When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth of the child.
When a fetus is aborted because of a congenital anomaly, or is miscarried, what is considered the onset date of the Adverse Event?
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.
If information is available as to the time during pregnancy when exposure occurred, where should this be input in the report?
If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5.
In B5: Describe the Event or Problem, what should be avoided when writing your narrative?
- 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.
What is Section B?
Adverse Event or Product Problem
