Published by Consumers should report serious adverse events related to human medical products to the U.S. Food & Drug Administration (FDA). As attorneys experienced in product liability and FDA regulatory matters, we help clients understand how to document and report these incidents effectively. These reports can include side effects from dangerous drugs, over-the-counter medications, dietary supplements, and complications or injuries arising from defective medical devices.
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Steps to Filing an Adverse Event Report with the FDA
The FDA has made reporting unsafe human medical products straightforward. You can submit a report online through the FDA’s MedWatch program, which is the official system for reporting serious adverse events associated with FDA-regulated products including medications, medical devices, and dietary supplements.
Link to FDA Form: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Reporting an adverse event to the FDA creates an official record that may be important if you later pursue legal action or join a class action lawsuit related to a defective or dangerous product. The FDA shares adverse event data with the public, which can help identify patterns of harm and lead to product recalls, label changes, or other regulatory actions that protect consumers.
Can a lawyer file an FDA adverse event report?
Yes.
Sometimes these reports are and can be made by an injured consumer’s legal counsel, i.e. their attorney or lawyer that is investigating the merits of a product liability lawsuit on behalf of the injured individual.
Information You Should Report to the FDA
- Unexpected side effects or adverse events can include everything from skin rashes to more serious complications.
- Product quality problems such as information if a product isn’t working properly or if it has a defect.
- Product Use/Medication Errors that can be prevented. These can be caused by various issues, including choosing the wrong product because of labels or packaging that look alike or have a similar brand or generic names. Mistakes also can be caused by difficulty with a device due to hard-to-read controls or displays, which may cause you to record a test result that is not correct.
- Therapeutic failures. These problems can include when a medical product does not seem to work as well as when you switch from one generic to another.
Types of FDA Regulated Products You Can Report Through the MedWatch Reporting System
- Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
- Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.
- Medical devices such as diabetes glucose-test kits, hearing aids, breast pumps, and many more products.
- Combination products such as prefilled drug syringes, auto-injectors, metered-dose inhalers, contact lens coated with a drug, and nasal-spray.
- Special nutritional products such as dietary supplements, medical foods, and infant formulas.
- Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes, and tattoos.
- Food such as beverages and ingredients added to foods.
Contact a Product Liability Lawyer
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in dangerous drug lawsuits, defective medical device lawsuits, dietary supplement lawsuits, and food poisoning lawsuits. We handle these types of product liability lawsuits nationwide and are currently accepting new defective or dangerous product cases in all 50 states.
Free Confidential Case Evaluation: if you or a loved one have been injured by an unsafe product, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.