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 mother using a nipple shield reports a blister forming under the shield after each feed. Which action best reflects adverse event reporting protocol?
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.
When must a healthcare facility submit a Medical Device Report (MDR) to the FDA under the Safe Medical Devices Act?
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.
A lactation educator documents that an electric breast pump rental caused breast tissue trauma in three separate clients. Which reporting pathway is MOST appropriate?
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.
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?
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.
Which element is NOT typically required in a MedWatch 3500A voluntary report for a lactation product?
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.
A CLE learns a compounded domperidone prescription caused cardiac arrhythmia in a breastfeeding mother. Which reporting system is MOST relevant?
Answer: MedWatch for drugs and supplements
Drug-related adverse events, including those involving compounded medications like domperidone, are reported through FDA MedWatch.
Under HIPAA, when sharing adverse event information with the FDA, which patient data may be included without explicit written authorization?
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.