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In an effort to assist mandated reporters understand their critical role in protecting children by recognizing and reporting child abuse, DCFS administers an online training course entitled Recognizing and Reporting Child Abuse: Training for Mandated Reporters, available 24 hours a day, seven days a week.

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Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected counterfeit medical products to FDA through MedWatch. The instructions on this webpage apply to both consumers and healthcare professionals who are submitting reports on a voluntary basis, and to certain entities with mandatory reporting obligations under FDA regulations.

Voluntary Reporting by Consumers, Patients and Health Professionals

In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

  • This form CANNOT be used to report a stolen vehicle (Contact 713-884-3131 to report auto theft). Your responses to the questions on the next several screens will help ensure that your incident is eligible for an online police report. After reading the above, Click here to continue.
  • If this is an emergency please call 9-1-1. If you want to provide a crime tip, visit the Crime Stoppers website at www.sdcrimestoppers.com. The Citizens' Online Police Reporting System allows you to submit a police report online and print a copy for your records. Please answer the following questions. Your answers will determine whether filing a report online.
  • Here are the steps users will follow to file a report online: Click on the Online Reporting Tool to choose your event type and start your report. Name and email address are required to ensure that all complainants may be contacted for further information if necessary. Follow the prompts at the bottom of each screen to complete your report.
  • See the words: “Your online police report has been submitted” showing that your police report is complete. Upon the Salt Lake City Police Department’s acceptance of your report you will: Be given a permanent police report case number. Be able to print a copy of the police report to keep for your records. Comience el Informe.

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If the link to the PDF voluntary reporting form (below) does not automatically open the form in your browser, try installing the latest version of the free Adobe Acrobat Reader.

For Use ByForm

Health Professionals, Patients, and Consumers
Easy online, voluntary reporting for health professionals, patients, and consumers.

Online Reporting Form

Health Professionals
For use by health professionals, consumers, and patients. Instructions for Completing Form FDA 3500

Form FDA 3500 - Voluntary Reporting(pdf)

Patients and Consumers
A consumer-friendly version of the 3500 reporting form.

Form FDA 3500B - Voluntary Reporting for Consumers(pdf)

Industry (Mandatory)
Reporting by IND reporters, manufacturers, distributors, importers, user facilities personnel.

These particular reports must be submitted in an electronic format that FDA can process, review, and archive. See the guidance for industry “Providing Submissions in Electronic Format —Postmarketing Safety Reports”.

Pacientes y consumidores
Para uso de pacientes y consumidores.

Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B(pdf)

Regulated Medical Product Website

Tobacco, Cigars, E-cigarettes/Vaping and Chewing Tobacco
For use by health professionals, consumers, and patients.

Vaccines
For use by health professionals, consumers, and patients.
Vaccine Online Reporting

Animal Food, Drugs and Devices
For use by industry, veterinarians and animal owners.

Report a problem with an animal or veterinary product
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Resources For You

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