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FORM FDA 3500 For VOLUNTARY reporting of adverse events, product problems and product use medication

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The document is a MedWatch Form FDA 3500, used for the voluntary reporting of adverse events, product problems, and medication errors related to drugs, medical devices, and other health products. It includes sections for patient information, details about the adverse event or product problem, and instructions on how to report these incidents to the FDA.

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What is the difference between FDA Form 3500 and 3500A?

The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

What are the 4 criteria for adverse event reporting?

The reporting of medication errors to FDAs Adverse Event Reporting System (FAERS) is voluntary in the United States, though FDA encourages healthcare providers, patients, consumers, and manufacturers to report medication errors, including circumstances such as look-alike container labels or confusing prescribing

How do I submit a FDA form 3500A?

Please submit the completed MedWatch 3500A form along with information to support the report, such as scans of labels and images of the serious adverse event, to FDA via: Email (preferred method for faster processing and reviewing): CosmeticAERS@fda.hhs.gov.

Is reporting of medication errors to the FDA mandatory?

Report a problem with FDA-regulated products Call 1-888-INFO-FDA (1-888-463-6332). Call the FDA Consumer Complaint Coordinator for your state or region.

How do I report an adverse event to FDA?

What to Report on Form FDA 3500 and FDA 3500B Voluntary Adverse Event Report Form Complete voluntary Form FDA 3500 online. Call 1-800-FDA-1088 to report by telephone.

What is FDA Form 3500 for voluntary reporting of adverse events and product problems?

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.

How do you report an adverse event or medication error to the FDA?

To submit your voluntary report: Complete voluntary Form FDA 3500 online. Call 1-800-FDA-1088 to report by telephone.

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