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October 31, 2017 Practice Points

The FDA’s MAUDE: Useful Insights for Medical Devices

By Patrick J. McGrath

Gathering background research about a product liability issue through publicly available information often leads practitioners to the FDA’s Manufacture and User Facility Device Experience database (MAUDE).  MAUDE annually captures several hundred thousand medical device reports (MDRs) regarding alleged medical device failures or adverse events. MAUDE contains a treasure trove of useful information, but it is certainly not a panacea. Practitioners must understand MAUDE’s limitations and navigate through a challenging search process to use this tool effectively.

Effective Uses of MAUDE
When product liability matters involving medical devices are litigated, the information developed during the discovery phase typically serves as the foundation for any insights, strategies, or analysis. MAUDE is more likely used prior to litigation and formal discovery or to provide a wider perspective about topics likely to be encountered. Possible effective uses of MAUDE include the following:

  • Identify other manufacturers or related products experiencing similar issues;
  • Assess the overall nature and severity of adverse events;
  • Determine general chronological trends in reported events;
  • Early assessments of risks linked to a category of medical devices; and
  • Comparison to information contained in external studies, technical papers, or governmental agency reports.

Search Tips
The following three search tips represent a brief subset of tips compiled through experience performing thousands of searches in MAUDE:

  1. MAUDE search functionality allows only 500 records to be returned from each search. To overcome this issue, perform multiple searches of narrow date ranges, export the results of each search into Microsoft Excel, and merge all the exported data into a single table.
  2. Significant variations in the reported product, brand name, or manufacturer exist. The search process needs to account for all possible variations to prevent utilizing incomplete results. To develop a list of possible variations, search a narrow time range for the target product type (e.g. search “acetabular” in the brand name field), and identify all relevant variations in the manufacturer and/or brand name to narrow or broaden your search as needed.
  3. If all else fails (and time permits)—one can always submit a FOIA request to obtain the information sought.

One needs to fully understand the limitations of MAUDE to avoid making overreaching conclusions or providing erroneous insights. The FDA provides a clearly delineated list of limitations on its search page. Bringing context to a subset of these limitations offers a road map to avoid the most common pitfalls.

  1. Redundancy: MAUDE may contain multiple MDRs for the same event because MDRs can be submitted separately by a hospital, a patient, a doctor, a manufacturer, an importer, or others.
  2. Incomplete: Mandatory reporting is required under certain circumstances. However, much of the information gathered is provided voluntarily. The early reporting of adverse events may be understated until publicity or general awareness about an alleged product defect occurs.
  3. Time bound: Web searchable data in MAUDE is limited to adverse events reported in the past 10 years.

Patrick J. McGrath is a managing director at Navigant Consulting, Inc., in Chicago, Illinois.

Navigant Consulting is a corporate sponsor of the Section of Litigation. Neither the ABA nor ABA entities endorse non-ABA products or services. This article should not be construed as an endorsement.

Copyright © 2017, American Bar Association. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or downloaded or stored in an electronic database or retrieval system without the express written consent of the American Bar Association. The views expressed in this article are those of the author(s) and do not necessarily reflect the positions or policies of the American Bar Association, the Section of Litigation, this committee, or the employer(s) of the author(s).