Adverse Event Reporting Form

Definition:

An adverse event is any observation in animals or humans, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any extralabel use) of a product, including events related to a suspected lack of expected effectiveness. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis. 

Where will Management Report?:

• All products or devices – report the problem to the manufacturer, the contact information for which is likely on the label or other packaging of the product or device. Manufacturers are required to report adverse events to the oversight agency.
• Animal foods and FDA-approved products, such as animal medications and devices –report the adverse event to the FDA online or by calling 1-888-FDA-VETS (1-888-332-8387).
• USDA-approved products, such as animal vaccines – report the adverse event to the USDA APHIS Center for Veterinary Biologics online or by calling 800-752-6255.
• EPA-approved products, such as certain flea and tick products and other pesticides – report the adverse event to the National Pesticide Information Center online or by calling 800-858-7378.