Students and Health Professionals
We’ve provided case studies for the four categories of problems with medical products. You will have an opportunity to practice completing FDA Form 3500, our voluntary reporting form for health professionals, using these case studies. We encourage you to also become familiar with our form for consumers, (FDA Form 3500B), and educate your patients on reporting adverse events.
These case studies are based on actual reports received by the FDA and selected for this portal because of the quality of the report. Personally identifiable information has been changed to maintain confidentiality. To begin, click on one of the case studies.
NOTE: This is a training site; therefore, reports you complete will not be saved and submitted to FDA. To submit an actual report, go to the MedWatch Online Voluntary Reporting page.
Problem with Different Manufacturer of Same Medicine
Any differences in therapeutic response after switching from one manufacturer to another.