ArticleEGEMS (Washington, DC)2017
A Primer to the Structure, Content and Linkage of the FDA's Manufacturer and User Facility Device Experience (MAUDE) Files.
Article in EGEMS (Washington, DC), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed.
- Product and Equipment Coding in National Practitioner Data Bank Malpractice Payment Reports, 2019-2025.Cureus · 2026Article
- Adverse-event reporting profiles of the Intuitive SureForm robotic stapling system in the FDA MAUDE database differ by product code: a comparison of GDW- and NAY-coded reports.Journal of robotic surgery · 2026Article
- Maxillary sinus-related adverse event reports associated with endosseous dental implants in the FDA MAUDE database: a retrospective text-mining analysis.BMC oral health · 2026Article
- Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices.JAMA network open · 2026Article
- Scaling medical device regulatory science using large language models.NPJ digital medicine · 2026Article
- Real-World Medical Device Reports of SpaceOAR Hydrogel Spacer: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) Database.Advances in radiation oncology · 2025Article
- Acute clinical adverse events associated with the LUCAS chest compression system.Resuscitation plus · 2025Article
- Acute Clinical Adverse Outcomes Associated With the Cor-Knot.Annals of thoracic surgery short reports · 2025Article
- An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods.Therapeutic innovation & regulatory science · 2025Article
- Percutaneous interventions for pulmonary embolism.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Review
- Analysis of reported adverse events of pipeline stents for intracranial aneurysms using the FDA MAUDE database.Journal of cerebrovascular and endovascular neurosurgery · 2023Article
- Percutaneous treatment options for acute pulmonary embolism: a clinical consensus statement by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function and the European Association of Percutaneous Cardiovascular Interventions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022Article
- A Descriptive Analysis of Capsule Endoscopy Events in the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.Journal of digestive endoscopy · 2021Article
- Descriptive analysis of postmarket surveillance data for hip implants.Pharmacoepidemiology and drug safety · 2020Article
- Immediate and late impact of reperfusion therapies in acute pulmonary embolism.European heart journal supplements : journal of the European Society of Cardiology · 2019Article
- Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database.Journal of diabetes science and technology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
INTRODUCTION AND
backgroundThe US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database is a publicly available resource providing over 4 million records relating to medical device safety. Using downloadable MAUDE files avoids limitations of the online MAUDE search interface. However, naive file usage can result in errors, while independent discovery of the nuances required to correctly work with the database can be time-consuming. Practical information is provided to shorten this learning curve and obtain accurate results when using the MAUDE database files. MAUDE FILE DESCRIPTIONS: The MAUDE database consists of 135 fields in four primary (Master Event, Device, Patient, Text) and two supplemental (Device Problems and Problem Code Descriptions) file types. When combined, these six files provide a detailed account of an adverse event or product problem report. Website instructions for joining the files are incomplete. Comprehensive details are provided to enable precise file linking. LESSONS LEARNED: MAUDE files have irregularities that must be understood to download and work with the data efficiently. Accurate results depend upon combining the files correctly and understanding the difference between report and event denominators. Appreciating data availability can facilitate successful MAUDE investigations.
conclusionThe MAUDE database can provide key insights about medical device safety. Detailed information is provided about the structure, content and interrelationships of the MAUDE database files to enable investigators to use this valuable resource more quickly and accurately.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.