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How to fill out the Medwatch Form online
The Medwatch Form is essential for voluntary reporting of adverse events, product problems, and errors related to medical products. This guide will walk you through each section of the form, ensuring you provide accurate and comprehensive information.
Follow the steps to successfully complete the Medwatch Form online.
- Press the ‘Get Form’ button to access the Medwatch Form and launch it in your editor.
- Complete Section A: Patient Information. Provide details such as patient identifier, age or date of birth, sex, and weight. Ensure all information is accurate to maintain confidentiality.
- Fill in Section B: Adverse Event, Product Problem, or Product Use Error. Indicate the type of incident and describe it, checking all applicable boxes related to outcomes and interventions required.
- Provide details in Section C regarding the availability of the product for evaluation. Note whether the product is available for FDA examination.
- In Section D, list the suspect products associated with the event. Input the dose, frequency, and route of administration, as well as the dates of use.
- Move to Section E. If applicable, describe the suspect medical device, including brand name, model number, and any relevant identification numbers.
- Document any other concomitant medical products in Section F, excluding those used to treat the adverse event.
- Finish by completing Section G: Reporter information. This is where you will provide your contact details for any necessary follow-up.
- Once all sections are filled out, review your inputs for accuracy. Save changes, then download, print, or share the completed form as needed.
Start filling out the Medwatch Form online today to report any adverse events or product issues.
“A MedWatch Form is used to report an adverse or sentinel event to MedWatch” - the United States Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program. Founded in 1993, the MedWatch program was established by the FDA to help collect data on adverse events in the healthcare industry.
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