Hi guys,
Can anyone give me information on how to fill out a Maude report? i.e. Where do I go to locate one and exactly what is the purpose?

Thanks a million, Kim

:D HI RIF!

I am no good at posting links, but the webiste address to the FDA where MAUDE reporting can be done is www.fda.gov/medwatch or www.fda.gov/cdrh. It is pretty user friendly. Just take a look around once you get to the site and you'll be able to find where to click to make a report. The online form is pretty easy and basically walks you thru what the FDA wants to know. You can also go to the same site and use their search to find MAUDE reports.

There are several purposes to MAUDE reporting. Once a report is submitted, the manufacturer is made aware that one has been made, and they are required to investigate and answer the claim(s) in the report. Keep in mind that Cyberonics investigates themselves, and as you read thru reports they have answered, you will find they have typical answers that sway the FDA from thinking the device caused any issues. Typical answers are "User Error" and "Good Faith Attempts" to gather information when they don't want to answer or plain and simple don't want to admit the device caused the problem. They also like to give the answer that some things are known side effects. Also, most answers include they tested the device and it was operating properly-even if multiple doctors reported they tested the device (while it was still in the patient), and it showed high lead impedence, etc. Anyone can make a MAUDE report ie: the patient, their caregiver, the doctor, the manufacturer, etc.

Please also keep in mind that Cyberonics is not good at (for lack of better terms)answering the FDA, and as you may have read in another thread started by NancyB, they have been issued warning letters by the FDA for not answering in the governed time mandated by law. The FDA has allowed them to basically continue to get away with this bad practice, although they have threatened to impose sanctions, etc.

MAUDE reporting is very important so the FDA is aware of adverse events and side effects. History has shown with big pharma that it doesn't take all to many MAUDE reports to recall a med for serious side effects and even a couple deaths, but for some reason it is different for medical devices. Please take a look-see at the Legislative and Activism forum where you can find the thread Adverse Events. There are approx. 6 pages worth of MAUDE reports there, most regarding cardiac events with VNS.

I hope some of this info has been helpful to you! Please do keep in touch and let us know how things are going for you!

Take care!
B)

Hi Retiredinfla,

Filling out the report is a simple process. They walk you right through it.

Report your problem at this link.

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

Below is the response i received from the FDA when I asked what the purpose was of filing a report.

Our FDA statisticians and other scientists study the reported adverse events in light of numerator and denominator data. This means they analyze the quantity of problems reported in comparison to the quantity of the particular device in distribution. This information, along with other pertinent reports, is used to determine appropriate follow-up and regulatory action.

:D

THANKS a bunch for posting the link Dennis! I appreciate you!

B)

:) HI RIF!

We haven't heard from you in awhile-how are things going?

Hope you are doing alrighty. Please do keep in touch!
B)