FDA MAUDE Dataset

## Overview

Unlock medical device safety intelligence from **22M+ adverse event reports** spanning decades of FDA MAUDE data. The Manufacturer and User Facility Device Experience (MAUDE) database captures every reported medical device safety signal in the United States, providing the foundation for device safety surveillance, competitive intelligence, and regulatory compliance.

**Dataset Size:** 100+ GB | **85M+ records** | **Updated weekly**

> **[Start Free Trial](https://trial.dataplex-consulting.com)** | **[Purchase Full Access](https://checkout.dataplex-consulting.com/b/aFa4gsg9R8m413yfWsbQY04)**

### What's Included

- **device__events** - Core adverse event reports with cleaned, normalized event information (22M+ reports)
- **device__events_devices** - Device specifications, manufacturers, and FDA classifications (38M+ records)
- **device__events_patients** - Standardized patient demographics with age/weight normalization (25M+ patients)
- **device__events_classifications** - Product problems, remedial actions, and report types
- **device__events_text** - Searchable narrative descriptions of device events
- **device__device_classification** - FDA regulatory classification with risk levels (7K+ classifications)
- **device__agg_competitive_intelligence** - Market share and competitive benchmarking
- **device__agg_executive_dashboard** - High-level KPIs for executive reporting
- **device__agg_manufacturer_adverse_events** - Manufacturer risk profiles
- **device__agg_regulatory_compliance** - Compliance monitoring metrics
- **device__agg_safety_trends** - Time-series safety trend analysis

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## Use Cases

### Medical Device Companies
- **Post-market surveillance**: Monitor safety signals across your device portfolio
- **Competitive intelligence**: Benchmark adverse event rates against competitors
- **Regulatory submissions**: Support 510(k) and PMA applications with real-world evidence
- **Quality management**: Track product problems and corrective actions

### Healthcare & Research
- **Safety signal detection**: Identify unusual adverse event patterns early
- **Risk stratification**: Analyze safety profiles by device class and medical specialty
- **Patient outcome analysis**: Track death, hospitalization, and disability rates
- **Device recall analysis**: Monitor recall patterns and manufacturer responses

### Consulting & Investment
- **Due diligence**: Assess device manufacturer risk profiles for M&A decisions
- **Market intelligence**: Size the safety burden by medical specialty
- **Regulatory risk assessment**: Evaluate compliance patterns and reporting delays
- **Manufacturer benchmarking**: Compare safety performance across competitors

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## Data Quality & Updates

- **Source**: FDA MAUDE (Manufacturer and User Facility Device Experience) database
- **History**: Complete data back to 1991
- **Updates**: Weekly from FDA, processed twice daily
- **Data Quality**: Patient ages standardized to years, weights to kilograms
- **Classifications**: Linked to FDA product codes with risk levels (Class I, II, III)

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## Getting Started

### Start a Free Trial

Get 14 days of access to explore the FDA MAUDE dataset:

**[Start Free Trial](https://trial.dataplex-consulting.com)**

Trial includes:
- Full schema access with sample data
- Pre-built analytics tables
- Databricks notebook with example queries

### Get Full Access

Ready for production use? Get unlimited access to all 22M+ device adverse event reports:

**[Purchase Full Access](https://checkout.dataplex-consulting.com/b/aFa4gsg9R8m413yfWsbQY04)**

Full access includes:
- Complete historical data (1991-present)
- All 85M+ records across all tables
- 5 pre-aggregated analytics models
- Weekly updates within days of FDA release
- FDA device classification integration

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## Documentation & Support

- **Full Documentation**: [docs.dataplex-consulting.com/fda-maude-dataset](https://docs.dataplex-consulting.com/healthcare-data-catalog/fda-maude-dataset)
- **Data Dictionary**: Comprehensive field-level documentation
- **Sample Notebooks**: Ready-to-run Databricks notebooks
- **Support**: [e-mail]

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*Data provided by Dataplex Consulting | [dataplex-consulting.com](https://dataplex-consulting.com)*