FDA Updates Consumers on How to File Adverse Event Reports

March 13, 2017

By Ashley Lombardo

The Food and Drug Administration (FDA) has reclassified the vaginal mesh medical device to reflect a higher risk of adverse side effects after thousands of women submitted reports outlining the severity of their experiences with the device.

Manufacturers may flounder in informing the FDA of product failures. It is unclear whether they’re protecting profits or are genuinely unaware of the issue. The FDA issued a guideline to help consumers better understand the adverse event reports—how, and when, to file. It’s up to the public to share their stories and prompt change from the agency.

About Adverse Event Reports

Adverse event reports are crucial to alerting Americans about dangerous drugs and defective medical devices. The adverse event systems inform agencies about unknown risks, prompting them to influence labeling updates, issue safety communications and even remove products from the market.

“If you have a problem or concern about any of the products that the agency regulates, the FDA wants to hear from you,” the agency wrote on in a consumer update. The FDA lists all the products they are charged with regulating, including:

human prescription and over-the-counter (OTC) drugs
medical devices
foods, including dietary supplements, infant formulas, beverages, and ingredients added to foods
veterinary products, including foods and drugs for animals
electronic products that give off radiation
biologics, including vaccines, blood and blood components, and tissues for transplantation
cosmetics
tobacco products

How To File A Report

The FDA encourages you to report negative experiences with pharmaceuticals and health care products, including cosmetics. If you think a product has failed, or if you believe that it may have caused a side effect or complication, you should alert the FDA.

If your experience falls within one of the categories below, you are encouraged to submit your information:

Unexpected side effects or adverse events
Product quality problems
Potentially preventable mistakes
Therapeutic failures
Food concern

Individuals have the option to submit complaints to the FDA by phone, mail, or online. If you prefer to provide information over the phone, the FDA has designated districts. Each region is assigned an FDA Consumer Complaint Coordinator, for which the number can be found online.

If you plan to report to the FDA online, there are various systems in place. The FDA non-emergency reporting page lists information on reporting specific, regulated products to the proper system, such as MedWatch, The FDA Safety Information and Adverse Event Reporting Program; VAERS, The Vaccine Adverse Event Reporting System; or the Safety Reporting Portal.

In the consumer update, the FDA encouraged individuals to be as detailed as possible. Users should submit adverse event reports even if they cannot be certain of complications with a product or procedure. Reports should include the name, age, gender and ethnicity of the individual, along with the name of the product and any packaging codes that could help with identification.

The report should include a description of the consumer's experience with the product, in addition to how symptoms changed if product use was discontinued. Regardless of whether you chose to seek medical attention, the FDA encourages you to file a report. If you did seek medical assistance, the treatment information should also be included.

Adverse event reports are essential to the health and safety of our nation. If you've been injured by a dangerous drug or device, be vigilant and file a report.

Ashley Lombardo

Ashley Lombardo is a reporter, editor and photographer currently based in Los Angeles, CA. She studied journalism and cultural anthropology with a focus on long-form, narrative, investigative features. In her spare time, she loves seeing live jazz and funk music.

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FDA Updates Consumers on How to File Adverse Event Reports

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How To File A Report

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