Certified Lactation Specialist Adverse Event Reporting 2

Question 1

A lactation consultant documents that an infant developed a rash after the mother applied a lanolin-based nipple cream. Which reporting pathway is MOST appropriate?

Accepted Answer

File a MedWatch report with the FDA

Answer

Adverse reactions to topical products used during breastfeeding should be reported to the FDA via MedWatch (Form 3500) as they involve a cosmetic or drug product.

Question 2

Under FDA regulations, a breast pump sold as a Class II medical device that causes nipple tissue injury should be reported through which system?

Accepted Answer

MAUDE (Manufacturer and User Facility Device Experience)

Answer

Medical device adverse events, including injuries caused by breast pumps, are reported to the FDA's MAUDE database.

Question 3

A mother reports that her prescription domperidone (obtained abroad) caused a cardiac arrhythmia. As the lactation consultant, your FIRST action should be:

Accepted Answer

Advise discontinuing domperidone and refer her to her prescribing provider immediately

Answer

Patient safety is the immediate priority; the mother must be referred urgently to her provider, after which the adverse event should be documented and reported.

Question 4

Which of the following is the CORRECT definition of a 'serious adverse event' as defined by the FDA?

Accepted Answer

An event resulting in death, hospitalization, disability, or requiring medical intervention

Answer

The FDA defines a serious adverse event as one resulting in death, life-threatening situation, hospitalization, disability, congenital anomaly, or requiring medical or surgical intervention.

Question 5

A hospital-employed lactation consultant discovers that a donated human milk batch was contaminated. Which reporting obligation applies FIRST?

Accepted Answer

Notify the human milk bank, hospital infection control, and the FDA if a regulated product is involved

Answer

Contaminated donor human milk is a patient safety issue requiring immediate notification of the milk bank, hospital infection control, and potentially the FDA if it qualifies as a regulated product.

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Adverse Event Reporting 2