https://www.accessdata.fda.gov/scripts/medwatch/

ALL, HERE IS AN EVEN BETTER PLACE TO REPORT YOUR LASIK OUTCOME!

MedWatch Online Voluntary Reporting Form (3500)
A Message About HIPAA Compliance for Reporters to FDA MedWatch


Our MedWatch Online form is available to you for the voluntary reporting of serious adverse events, potential and actual medical product errors, and product quality problems associated with the use of FDA-regulated drugs, biologics, devices, and dietary supplements.

With the click of a button, you can complete, print, and submit the voluntary MedWatch Form (3500) online through the World Wide Web.

The MedWatch Online application uses Secure Socket Layers (SSL) and Pretty Good Protection (PGP) to encrypt and ensure the security and confidentiality of your MedWatch submission across the Internet.

We want to make it easy for you to submit your information successfully. Before beginning the submission process, please take a few minutes to review the information below.

When you are satisfied with the completeness and accuracy of the information in your submission, you must click on the SUBMIT AND FINISH button. When your information is transmitted, you will see a screen that thanks you for your report and tells you to expect to receive an e-mail message confirming your submission. If you do not receive this e-mail confirmation within several hours, your report may not have been received. You may contact us by phone at 1-800-FDA-1088 and press [0].


This online form is only for VOLUNTARY reporting. Mandatory adverse event reporting is not available online. Risk Managers and other personnel within User Facilities must use the MedWatch 3500a Mandatory Reporting Form. Download the 3500a Form from the Medwatch "Download Forms" web page.

In order to use the MedWatch 3500 Online form, you will need one of the supported Web Browsers listed below:

Netscape Navigator 7.x or higher

Microsoft Internet Explorer 5.x or higher

If you use a version older than the two above, you may have difficulties viewing the PDF file. Please check with your particular supplier for instructions. If you have any difficulties viewing the PDF files with the two above listed browsers, please follow the instructions on the PDF advisory/tips page. Upgrading your browser is free.

You may review or print detailed general instructions before beginning - just visit our instructions page. You may also reach online help during your submission by clicking on the help button. The help launches from the application into a new browser window. To return to the Online form, just close the new browser window.

After you complete the online form, you can view your submission as an Acrobat Reader (.pdf) file. If you want to print a copy of the completed form or save it to your computer before you submit it to FDA, you must use this feature. If you don't have this application available, you can download it free from the Adobe Acrobat Reader download site.
VERY IMPORTANT: If you have viewed, printed, or saved your submission to your computer in Acrobat Reader, you MUST return to the Online form to submit it to FDA. To accomplish this, click on your browser's BACK button, or close the new window, whichever is appropriate.

Click the button below to begin the MedWatch Online reporting form.


Please report any questions, problems, or suggestions that you may have about the MedWatch Online application by using our comments and feedback form.


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Web page updated July 19, 2002.