# #410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2025-06-09
- Length: 50m
- Episode: 410
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-09-410-is-the-maude-database-broken-an-insiders-take-on-adverse-event-reporting-fai
- Listen: https://podcast.greenlight.guru/episode/410-maude-whats-right-whats-wrong

## Summary

Regulatory expert Mike Drues joins host Etienne Nichols to critique the FDA’s MAUDE database, arguing that widespread late reporting and poor data hygiene undermine its safety mission. Drues highlights that nearly 30% of reports are late, with major manufacturers like Medtronic, Becton Dickinson, and Dexcom accounting for a disproportionate share of violations. The discussion covers the legal risks of non-compliance, the misuse of MAUDE data for competitive analysis, and recommendations for modernizing the system with AI-driven cross-referencing and tiered reporting urgency.

## Outline

1. Introduction: Mike Drues and the MAUDE Database
2. Defining Adverse Events and MAUDE's Limitations
3. Late Reporting Statistics and Major Violators
4. Legal Consequences and Expert Witness Insights
5. Root Causes: Investigation Delays vs. Withholding Info
6. Data Hygiene Issues and Duplicate Reports
7. Recommendations for Manufacturers and the FDA
8. Modernizing MAUDE with AI and Tiered Urgency

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

large enterprises

## Mentioned

- FDA (company)
- MAUDE (tool)
- Medtronic (company)
- Becton Dickinson (company)
- Dexcom (company)
- BioHorizons (company)
- Greenlight Guru (company)
- Phillips Respironics (company)

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- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (Let's Combinate)
- [014A - "The First P: Product" with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager) (Let's Combinate)
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- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-09-410-is-the-maude-database-broken-an-insiders-take-on-adverse-event-reporting-fai. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.