Exposing the LASIK Scam

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 Post subject: Reporting through the FDA's MedWatch program is easy
PostPosted: Sat Nov 26, 2005 3:42 am 
Site Admin
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Joined: Thu Jul 21, 2005 4:38 am
Posts: 33
The FDA currently receives more than 100,000 adverse event reports annually from manufacturers, hospitals, health professionals, and consumers. Reporting your adverse outcome through the FDA's MedWatch program is quick and simple. Consumers and health care professionals can report by telephone, fax, mail, or online, as follows:
  • Phone: 1-800-FDA-1088
  • Fax: 1-800-FDA-0178
  • Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
  • Web: www.fda.gov/medwatch
Your report will be entered into the publicly accessible Manufacturer User Facility and Distributor Experience (MAUDE) database. This database contains the following:
  • Voluntary reports since June 1993
  • User facility reports since 1991
  • Distributor reports since 1993
  • Manufacturers' reports since August 1996
You are encouraged to post a copy of your MedWatch complaint under the LASIK INDUSTRY PARTICIPANTS section of this bulletin board, and also on the alt.lasik-eyes newsgroup servers. One way of posting messages onto this newsgroup is through the Google portal. Posting copies of your MedWatch complaints on these highly indexed forums will ensure that others seeking information about adverse refractive surgery outcomes will find the information they seek when they use internet search engines.

Feel free to name your doctor and medical devices in your claim. Your right to petition the government is protected by the first ammendment, as is your right to republish the petition.

Last edited by Admin on Sat Nov 26, 2005 5:40 pm, edited 19 times in total.

 Post subject:
PostPosted: Sat Nov 26, 2005 5:16 am 
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Joined: Fri Nov 25, 2005 11:05 pm
Posts: 27
Location: world wide
What good is reporting your incident if the FDA isn't going to act on it until enough people get damaged?

We all need to make reports to get some critical mass at the FDA, and post our reports all over the worldwide web if we want to get anybody's attention.

 Post subject: How to search for MDRs in the FDA database
PostPosted: Sun Mar 19, 2006 4:14 am 

Joined: Sat Nov 26, 2005 1:23 pm
Posts: 2080
http://www.accessdata.fda.gov/scripts/c ... search.cfm

At the product code type in LZS for lasers, or HNO for microkeratomes. For Intralase (Intra-LASIK) type "Intra" for the Manufacturer.

Filing an MDR is sort of like voting. If you don't vote, you can't complain about who gets elected. If you don't file your MDR, you can't complain that the FDA is not doing anything about all of the problems.

Please file your MDR.

http://www.fda.gov/medwatch/report/cons ... nsumer.htm

Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

 Post subject: Medwatch online reporting
PostPosted: Mon May 29, 2006 1:06 am 

Joined: Mon Nov 14, 2005 4:28 pm
Posts: 643


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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