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U.S. Department of Health and Human Services
FDA MedWatchLearn
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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.

Adverse Effects -- skin problem

Adverse Effects

Any incident in which a medical product was suspected to have resulted in an undesirable experience for the patient.

product use error -- elderly couple with medication

Product Use Error

Any medication or medical product error regardless of patient involvement and outcome. Also report circumstances that have the capacity to cause error, such as similar label appearance.

product problem -- empty pill wrapper

Product Problem

Any concerns about the quality, authenticity, performance, or safety of any medication or device.

Problem with Different Manufacturer of Same Medicine -- different types of pens and fasls for insulin administration

Problem with Different Manufacturer of Same Medicine

Any differences in therapeutic response after switching from one manufacturer to another.

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