Important to Contact FDA with issues

• by djohnston
• 2016-05-22 11:05:23
• Complications
• 1435 views
• 4 comments

Consumers play an important public health role by reporting to the FDA unexpected side effects after using a medical product, or experiencing other problems with any products that the agency regulates.

Timely reporting enables the agency, if necessary, to promptly address the issue. There are a number of ways you can report problems to the agency, depending on the type of problem and product. When you submit a safety report through FDA’s Safety Reporting Portal, or any other way described below, you make a contribution to the safety of America's food supply and human medical products. The following tips and chart will help you make your report.

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Tips for Reporting

1. Report what happened as soon as possible after you discover a problem. Be prepared to provide the following information:
•names, addresses, and phone numbers of people affected
•your name, postal and e-mail address, and phone number
•name, address, and phone number of the doctor or hospital that provided emergency treatment
•product codes or identifying marks on the label or container
•name and address of store where product was bought and date of purchase
•name and address of company on the product label

2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that can help FDA trace the product back to the plant that manufactured it.

3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.

4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator. Consumers can also visit FDA’s Safety Reporting Portal to report a safety issue. To see a full list of products the FDA regulates, along with safety reporting information, visit the safety report directory. Using this portal also streamlines the process of reporting product safety issues to the FDA.

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How to Report

Below is a quick-reference guide for reporting problems to FDA regarding:

An emergency (serious, life-threatening event) involving FDA-regulated products (human and animal drugs, medical devices, biological products, foods, dietary supplements, cosmetics and radiation-emitting products).
•Call FDA's 24-hour emergency line at either 866-300-4374 or 301-796-8240, or
•FDA Consumer Complaint Coordinator in your state.
•You should also contact your health care professional for medical advice.

Serious side effects, product quality problems and product use errors involving human health care products. Human health care products include human drugs, medical devices, blood products and other biologics (except vaccines), dietary supplements, infant formulas and medical foods such as nutritional supplements.
•Report to MedWatch, or call 800-332-1088 to request reporting form. MedWatch is your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
•Call FDA Consumer Complaint Coordinator in your state.
•You should also contact your health care professional for medical advice.

Food-related or cosmetic non-emergency (allergic reactions to a product with no allergens listed; a non-life-threatening foodborne illness) involving food and cosmetic products.
•Call FDA Consumer Complaint Coordinator located in the state where you reside; or if you are unable to contact a complaint coordinator, you can complete an electronic Voluntary MedWatch form or paper Voluntary MedWatch form that can be mailed to FDA.

(To report food products containing meat, poultry, and frozen, dried and liquid eggs, contact the US Department of Agriculture.)

An illness or injury associated with a vaccine
•Vaccine Adverse Event Reporting System (VAERS), or call 800-822-7967 to request reporting form.
•You can also contact your health care professional for medical advice.

A blood transfusion-related fatality
•Notification process for transfusion-related fatalities, call 301-827-6220 or e-mail fatalities2@fda.hhs.gov.

A clinical trial complaint
•Good clinical practice in FDA-regulated clinical trials.

FDA-regulated products sold online
•Reporting unlawful sales of products on the Internet.
•Report e-mail promoting medical products that you think might be illegal, and forward the email to webcomplaints@ora.fda.gov.
•If you are a consumer or health professional who wants to report a product problem, an injury, or an illness related to a food or cosmetic product, please contact a FDA Consumer Complaint Coordinator located in the state where you reside; or if you are unable to contact a complaint coordinator, you can complete an electronic Voluntary MedWatch form or paper Voluntary MedWatch form that can be mailed to FDA.