CLE Adverse Event Reporting 2

Question 1

A mother using a nipple shield reports a blister forming under the shield after each feed. Which action best reflects adverse event reporting protocol?

Accepted Answer

Report the nipple shield brand to MedWatch as a device-related adverse event

Answer

Nipple shields are FDA-regulated medical devices, so injuries attributable to their use should be reported via MedWatch in addition to clinical documentation.

Question 2

When must a healthcare facility submit a Medical Device Report (MDR) to the FDA under the Safe Medical Devices Act?

Accepted Answer

When a device is suspected to have caused or contributed to serious injury or death

Answer

Mandatory MDR reporting is triggered when a device is reasonably suspected of causing or contributing to serious injury, illness, or death.

Question 3

A lactation educator documents that an electric breast pump rental caused breast tissue trauma in three separate clients. Which reporting pathway is MOST appropriate?

Accepted Answer

Submit a MedWatch report to the FDA for each incident

Answer

Each device-related injury should be individually reported to FDA MedWatch, as electric breast pumps are Class II medical devices.

Question 4

A parent calls to report their infant had a choking episode with a slow-flow bottle nipple. As a CLE, what is the first documentation step?

Accepted Answer

Record date, time, product details, lot number, and the clinical description of the event

Answer

Thorough initial documentation—including product identifiers and event description—is the foundation for any subsequent adverse event report.

Question 5

Which element is NOT typically required in a MedWatch 3500A voluntary report for a lactation product?

Accepted Answer

Reporter's Social Security number

Answer

MedWatch forms require event description, patient outcome, and device identification but do not ask for the reporter's Social Security number.

(CLE) Certified Lactation Educator Practice Test

(CLE) Certified Lactation Educator Practice Test

CLE Adverse Event Reporting 2