How to File Your Own Device Complaint to the FDA

printer logoHOW TO FILE YOUR OWN DEVICE COMPLAINT
TO THE FDA –
©Peggy Day

You oe aomeone you know has been hurt by a device. You want to let the FDA know about it, but it is so complicated. Here is a step-by-step guide.

This worksheet works best if you print out these pages and fill them in advance. (Click here for a printable copy)  You’ll be ready to make the best, most effective report you can in one sitting. Settle in with a cuppa tea or whatever relaxes you.

Now: click on this link:   https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting.home

The first page you should see should look like this:

FDA MEDWATCH FRONT 1

Go ahead and click on “Consumer/Patient.”

On the next page, check the box for medical device.

FDA MEDWATCH 2

 

Next, check everything that applies:

FDA MEDWATCH 3

Write every detail you know about the situation. Don’t hold back, this is the place to let your feelings flow. Don’t worry, you can always file a new report if new information or new details come to you.

FDA MEDWATCH 5

If you have any lab results or information you’d like to make public, add them here.

FDA MEDWATCH 6

Add the date of the event if you know it. (Very important!)

FDA MEDWATCH 7

Here is where you fill in as much information about the device as you know. If you have no idea what the device is, write as much as you do know or write: “Unknown pelvic sling,” “Unknown hernia mesh,” etc. Do your best.

FDA MEDWATCH 8

FDA MEDWATCH 9

Some of the following information will be made available to others. You decide what you want to share.

FDA MEDWATCH 10

FDA MEDWATCH 11

FDA MEDWATCH 12

The following is information to identify the reporter (you). The more information you offer, the more credible your report will be.

FDA MEDWATCH 13

Should you decide to check the box below, be prepared to be contacted by the manufacturer of the device. Remember, their job is to protect the company, not to ensure or provide the best patient care.

FDA MEDWATCH 14

©Peggy Day





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