RAC US Exam Question No 36

Question No 36:

While reviewing complaint files for a drug-eluting stent, a single entity combination product, it was noticed that an adverse event had occurred and a patient was hospitalized for two additional days. Such an adverse event was a foreseeable event and the mechanical features of the stent contributed to the occurrence. As a regulatory professional, your decision regarding the adverse event report would be?

A. Report to FDA in a 15 Day Alert Report
B. No action is needed as ADE reporting is only required for serious and unexpected adverse events; this ADE is expected so no reporting is needed
C. Report to FDA in Form 3500A (MDR) within 30 days
D. Report to FDA within 7 calendar days

Answer: C