Certified Lactation Specialist Adverse Event Reporting 3

Question 1

A breastfeeding mother experienced severe sedation after taking an herbal galactagogue supplement. Since herbal supplements are regulated as dietary supplements, the adverse event should be reported to:

Accepted Answer

FDA via the Safety Reporting Portal under dietary supplement AE reporting

Answer

Dietary supplement adverse events are reported to the FDA through its Safety Reporting Portal; the FDA oversees supplement safety post-market.

Question 2

An infant develops apnea episodes after the mother takes a high-dose fenugreek supplement to boost milk supply. The lactation consultant should document this as which type of adverse event?

Accepted Answer

A neonatal adverse event secondary to maternal exposure

Answer

When maternal supplement use leads to infant symptoms via breast milk transfer, the adverse event is classified as neonatal/pediatric, secondary to maternal exposure, and should be reported accordingly.

Question 3

Which timeline does the FDA require for mandatory expedited reporting of unexpected serious adverse events for regulated clinical trials involving lactating participants?

Accepted Answer

15 calendar days

Answer

The FDA mandates expedited (15 calendar day) reporting for unexpected serious adverse events in regulated clinical investigations.

Question 4

A lactation consultant suspects that a newly marketed nipple shield caused nipple tissue necrosis in a patient. The consultant cannot identify the manufacturer. What is the best next step?

Accepted Answer

Contact FDA MedWatch, providing all available product details; FDA will investigate the manufacturer

Answer

Reports can and should be filed even when manufacturer information is incomplete; the FDA has investigative authority to identify the manufacturer.

Question 5

A lactation consultant employed by a medical device company that sells electric breast pumps is REQUIRED to report serious device-related injuries within how many days under 21 CFR Part 803?

Accepted Answer

5 days for events requiring immediate remediation; 30 days for others

Answer

Under 21 CFR Part 803, device manufacturers must report events requiring immediate remediation within 5 working days and other serious events within 30 days.

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Adverse Event Reporting 3