CLE Adverse Event Reporting 2 — Questions and Answers
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?
- Advise her to discontinue the shield and document the skin injury in her record
- Report the nipple shield brand to MedWatch as a device-related adverse event (Correct answer)
- Instruct her to apply lanolin and continue monitoring without formal documentation
- Refer immediately to dermatology without noting the device concern
Correct answer: Report the nipple shield brand to MedWatch as a device-related adverse event
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?
- Whenever a patient experiences any discomfort from a device
- When a device is suspected to have caused or contributed to serious injury or death (Correct answer)
- Only when the manufacturer requests a facility investigation
- When a device malfunctions but causes no apparent patient harm
Correct answer: When a device is suspected to have caused or contributed to serious injury or death
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?
- Notify the pump rental company only
- Submit a MedWatch report to the FDA for each incident (Correct answer)
- File a complaint with the state nursing board
- Send an email to the pump manufacturer's customer service
Correct answer: Submit a MedWatch report to the FDA for each incident
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?
- Record date, time, product details, lot number, and the clinical description of the event (Correct answer)
- Advise the parent to return the product and note the return in the chart
- Call the bottle manufacturer before documenting anything
- Reassure the parent and follow up in one week
Correct answer: Record date, time, product details, lot number, and the clinical description of the event
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?
- Description of the event or problem
- Patient outcome
- Reporter's Social Security number (Correct answer)
- Device brand name and model
Correct answer: Reporter's Social Security number
MedWatch forms require event description, patient outcome, and device identification but do not ask for the reporter's Social Security number.
Question 6: A CLE learns a compounded domperidone prescription caused cardiac arrhythmia in a breastfeeding mother. Which reporting system is MOST relevant?
- MedWatch for drugs and supplements (Correct answer)
- VAERS (Vaccine Adverse Event Reporting System)
- The National Poison Data System
- The Joint Commission Sentinel Event database
Correct answer: MedWatch for drugs and supplements
Drug-related adverse events, including those involving compounded medications like domperidone, are reported through FDA MedWatch.
Question 7: Under HIPAA, when sharing adverse event information with the FDA, which patient data may be included without explicit written authorization?
- Full name and home address for follow-up contact
- De-identified clinical data describing the adverse event (Correct answer)
- Social media profiles linked to the complaint
- Insurance billing codes only
Correct answer: De-identified clinical data describing the adverse event
HIPAA permits disclosure of protected health information to public health authorities like the FDA without patient authorization when necessary for public health activities.
CLE Adverse Event Reporting 2
A mother using a nipple shield reports a blister forming under the shield after each feed.
Which action best reflects adverse event reporting protocol?