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

We’ve provided case studies for four categories of problems with medical products. You will have an opportunity to practice filling out FDA Form 3500B, our MedWatch consumer reporting form, using these case studies. The case studies are based on actual reports received by the FDA. Information that may identify the patient, reporter, and product were changed for privacy reasons.

To begin, click on one of the case studies, read it, and fill out the form below the case based on the details of the person’s experience in the case.

NOTE: This is a practice site. Reports you complete here will not be saved and submitted to FDA. To submit an actual report, go to FDA MedWatch and fill out the online form or call our toll-free number, 1-800-FDA-1088, to request a consumer form.

Unexpected Side Effect

Unexpected Side Effect

You were hurt or had a bad side effect (including new or worsening symptoms) after taking a drug or using a medical device or product.

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

Problem with Different Manufacturer of Same Medicine

You had problems with how a drug, device, or medical product worked after switching from one maker to another maker.

product use error -- using a hammer on a screw

Product Use Error

You used the drug, device, or other medical product incorrectly which could have or led to a problem.

product problem -- drug quality problem

Product Problem

You noticed a problem with the quality of the drug, product or medical device.

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