How to Report Adverse Events to the FDA

Written By:
Jessie Paluch
Jessie Paluch

Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

TruLaw does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.

How to Report Adverse Events to the FDA

Reporting an adverse event to the FDA is an important tool for all consumers to make sure that only the safest and most effective drugs remain on the market.

Although reporting adverse events are very simple, the FDA reports that only about 10% of all adverse events are actually reported to the adverse event database.

The FDA compiles reports from doctors and consumers in a database called the “adverse event” database, or FAERS.

TruLaw encourages all consumers to report their adverse events to the FDA.

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Who Reports Adverse Events?

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the drugs, supplements or medical devices you use.

In some cases, the manufacturer of your drug or device may be required to report your injury or complication, but that is only if they know about it.

The FDA encourages doctors, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems to the FDA.

TruLaw also encourages all individuals and loved ones to report injuries, side effects and complications from the use of drugs, devices, and supplements to the FDA because it is vital to assure that only safe and effective medical products remain on the market.

How to Use the FDA MedWatch System

The FDA MedWatch Website is simple to use, it should take only a few minutes to get through the steps needed to report.

Specifically, the FDA MedWatch Website is looking for reports about a serious adverse event, product quality problem, product use error or therapeutic inequivalence/failure that you suspect is associated with the FDA product you use.

Serious adverse events generally include death, life threatening events, hospitalization or other serious medical events.

In order to file a report, you will need to tell the FDA minimal information about the problem (specifically about the device or drug used), about the patient, and about the person reporting the issue (if you are reporting for someone else).

The online form is very simple to use.

What problem did you have with the drug or device?

The FDA would like to know what kind of a problem was experienced and whether any medical intervention was required (including hospitalization and/or death), details about when and where the problem happened will be required.

If you have any relevant lab data or tests available, you can describe them but this is not necessary.

If the problem came from a medical device –  the FDA will need to know the name of the medical device but no further information is required.

If you know the company that manufactured the device, the model, lot, serial number and expiration date, you can provide this information to the FDA.

In addition, the FDA encourages you to provide information about who was operating the medical device when the problem occurred and details about an implant, if this is the problem device.

If you experienced side effects from a drug, compound or supplement – the FDA requires the name of the product as it appears on the box, bottle or package.

Any other information you have about this product is asked about, but not necessary.

You are able to add as many products as you had problems with on a single form.

The last thing the FDA requires is information about the patient, but a full name is not required.

Information about date of birth, weight, ethnicity, race and previous medical conditions and allergies will help the FDA to study the complication or side effect, but this information is not required to be provided.

The person reporting the form (whether this is the injured individual or someone else) is required to report their full name to the FDA, but, you are able to hide your identity from the manufacturer and no further information is required.

Written By:
Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

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