Adverse Event Reporting Flashcards
7 cards from real CLE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Adverse Event Reporting flashcards as text
A CLE employed by a WIC agency observes that a formula product distributed through the program may have caused gastrointestinal illness in several infants. Who should be notified FIRST?
Answer: The WIC state agency and FDA simultaneously
Government-distributed products involve both the administering agency (WIC state office) and the FDA; both should be notified promptly when a safety concern is identified.
What is the maximum timeframe the FDA generally expects for mandatory reports of unexpected serious injuries related to medical devices from user facilities?
Answer: 10 work days
Under 21 CFR Part 803, user facilities must submit MDRs for device-related serious injuries within 10 work days of becoming aware of the event.
A CLE discovers that a recalled breast pump model is still being rented at a local pharmacy. What is the MOST appropriate response?
Answer: Notify the pharmacy, advise clients not to use the device, and report to the FDA if harm has occurred
The CLE should alert the pharmacy to the recall, counsel affected clients, and submit an FDA adverse event report if any clients experienced harm from the recalled device.
Which statement BEST describes the concept of causality assessment in adverse event reporting for lactation products?
Answer: A plausible temporal relationship between product use and the event is sufficient to warrant reporting
Adverse event reporting systems accept reports based on suspected associations; reporters do not need to prove causation before submitting.
A lactation educator is asked to assist in developing a facility adverse event policy for lactation devices. Which regulatory document should serve as the PRIMARY reference?
Answer: 21 CFR Part 803 – Medical Device Reporting
21 CFR Part 803 establishes FDA requirements for Medical Device Reporting and is the authoritative regulatory source for device adverse event policies.
A mother reports that a lactation tea marketed to increase milk supply caused her infant to become lethargic and feed poorly. How should the CLE classify this event for reporting purposes?
Answer: Serious adverse event warranting both CAERS report and clinical evaluation of the infant
Infant lethargy and poor feeding following maternal ingestion of a supplement are signs of a potentially serious adverse event requiring FDA CAERS reporting and urgent clinical evaluation.
Under the Baby-Friendly Hospital Initiative, how does adverse event documentation for formula supplementation relate to quality improvement processes?
Answer: Adverse event data on supplementation practices informs protocol review and staff education
BFHI quality improvement relies on systematic data collection, including adverse events related to feeding practices, to refine protocols and training.