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Form Approved: OMS No. 0910-0291. Expires: 12/3112011 See OMS statement on reverse. U.S. Department of Health and Human Services ME DWATCH The FDA Safety Information and Adverse Event Reporting Program.

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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.

  1. Press the ‘Get Form’ button to access the Medwatch Form and launch it in your editor.
  2. 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.
  3. 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.
  4. Provide details in Section C regarding the availability of the product for evaluation. Note whether the product is available for FDA examination.
  5. 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.
  6. Move to Section E. If applicable, describe the suspect medical device, including brand name, model number, and any relevant identification numbers.
  7. Document any other concomitant medical products in Section F, excluding those used to treat the adverse event.
  8. Finish by completing Section G: Reporter information. This is where you will provide your contact details for any necessary follow-up.
  9. 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.

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“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.

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

MedWatch is FDA's program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors associated with FDA-regulated products.

User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

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.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232