FDA fixes another error with its MAUDE database

I feel like a broken record, but I am going to talk about another error in the MAUDE database.

For those playing along at home, the FDA tracks medical device malfunctions and adverse events using a database known as MAUDE. They are nice enough to make the entire database available for download. You can download the data files here. Last week, I noticed that one of the data files was missing reports from January 2018.

• I emailed them informing them of the error.
• They emailed me back explaining that everything was fine.
• I emailed them back, explaining that it wasn't.
• They emailed me back (see pic below) and fixed the issue.

I don't know how/why these errors keep cropping up, but it's the 3rd error I've found in MAUDE over the past year.

FDA Updates their MAUDE Production Database LIVE and on-the-fly

The FDA uses a data-base/search engine known as MAUDE to monitor the safety and malfunctions of FDA approved medical devices.

A few days ago, I downloaded the FDA's MAUDE "raw" data-set (located here). I do this a few times per month, and today I noticed that at least part of the data-set is corrupt. I won't go into the gory details, but some of the 2018 data seems to have been mistakenly vaporized from the current data-set.

While, I was trying to figure out what was corrupted, I ran a test search using the FDA's MAUDE search-engine (located here).

I searched for the word veritas and I got ZERO results.

Now, I KNOW there are reports in MAUDE involving the veritas collagen matrix because I've run the search before, so when I got ZERO results, I knew that not only were the "raw" data-files corrupt, but something was also corrupt with the FDA's live search-engine.

As I was writing my email to the FDA, I started to tell them that their error was NOT ONLY with the "raw" data-set, but their search-engine was corrupted, too!

Then I decided that I should take a screenshot of my search results just in case they thought I was crazy.

So, I re-ran the veritas search.

But this time, when I ran it, I got 62 RESULTS! See pic below. I started to think, "Maybe I am going crazy. Maybe I punched in the wrong search term, or maybe I selected an incorrect parameter."

But then, I ran the search again (2 minutes later), and I got 64 RESULTS!

Approximately 1 hour later, and we are up to 145 results.

So...just in case this is confusing....

• The FDA is correcting errors on its production database.
• In the middle of the day.
• On a Friday.
• And they're doing all of this while the search-engine is LIVE.
• I can tell because I'm watching it happen in real time.

To the database and software-dev people out there, that is some cowboy stuff.