Why Are One-Third of MAUDE Reports a Problem?

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing MAUDE safety reports and taking a look at what the issues are with them. More specifically, we’re digging in to find out why almost a third of the reports are delayed or incomplete. We’ll get insight on what these reports are, if they are important, and what should be done to improve that 30% figure. During this conversation, the following questions are addressed: First, Mike, if you would, please explain what the Manufacturer and User Facility Device Experience (MAUDE) Database is. What are the MAUDE reporting requirements? How well does the MAUDE reporting system work? Are there consequences for a delayed or incomplete report? Given the statistics, is the MAUDE database a reliable source of information for medical device manufactures? for clinicians? for patients? for anyone? What should manufacturers do? What should the FDA do? What else is important? What are today’s takeaways? Listen to this discussion and see if your company might have an issue with submitting a correct MAUDE report. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode. Send us Fan Mail For more medtech news and information, visit

You can listen to Why Are One-Third of MAUDE Reports a Problem? online on Radio and Podcast. Open the player on this page to stream the available audio.

Why Are One-Third of MAUDE Reports a Problem? is an episode from Medtech Matters by Medical Product Outsourcing.

This episode is 58:10 long.

This episode was published on Jun 10, 2025.

Yes. Use the heart button on the episode page to add it to your favorite episodes list.

Yes. This page shows related episodes from Medtech Matters when more episodes are available from the podcast feed.