Terms of Use

Effective 30 July 2026. Applies to maudedash.com and the MaudeDash software.

⚠️

MaudeDash is not medical advice. It is a research instrument for analysing a public database of adverse event reports. Nothing here is a diagnosis, a treatment recommendation, a safety determination, or a statement that any device is defective or unsafe. If you have a medical concern about a device, speak to a qualified clinician. To report a device problem to the FDA, use MedWatch.

1. What MaudeDash is

MaudeDash is a free, open-source analytics tool for the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. It reformats publicly released FDA data and computes descriptive and inferential statistics over it. The software is published under the MIT License; the underlying FDA data is a work of the U.S. Government and is in the public domain.

2. No affiliation with the FDA or manufacturers

MaudeDash is an independent project. It is not affiliated with, endorsed by, sponsored by, certified by, or reviewed by the U.S. Food and Drug Administration, any other government body, or any medical device manufacturer, distributor or healthcare organisation. References to the FDA identify the source of the underlying data and nothing more. Device names, brand names and manufacturer names shown by the tool are reproduced from FDA records and remain the trademarks of their respective owners; their appearance is nominative use for identification, not affiliation or endorsement.

3. The nature of the underlying data

You must understand the following before relying on any output. These are properties of MAUDE itself, not shortcomings of this tool.

There is no denominator. MAUDE records reports, not exposures. The number of devices in use is unknown, so no failure rate, incidence, risk or probability can be derived. Percentages shown by MaudeDash are shares of reports.
Reporting is voluntary for many sources and incomplete for all of them. Report volume reflects reporting behaviour, regulatory attention and publicity at least as much as device performance.
Reports are unverified. A report reflects what a submitter stated. The FDA does not confirm that the described event occurred as reported, nor that the device caused it.
Reports may be duplicated, amended or withdrawn, and the FDA revises the database retroactively. Figures change over time.
Disproportionality signals are hypothesis-generating only. A statistical signal is a prompt to investigate, never evidence of causation, defect, negligence or liability.

4. Permitted use

You may use MaudeDash for research, education, journalism, regulatory analysis, clinical quality improvement and other lawful purposes, including commercially, subject to the MIT License and these terms.

5. Prohibited use

You must not:

present MaudeDash output as an FDA finding, an official safety communication, or a regulatory determination;
state or imply that a device is defective, unsafe or caused harm on the basis of report counts or disproportionality signals alone;
use the tool or its output to harass, defame or make unfounded claims about any individual, clinician, facility or company;
attempt to re-identify any patient, reporter or other individual from narrative text or any combination of fields;
impose an unreasonable load on the service — for example by automated bulk downloading of the data files, scraping in a loop, or any activity that degrades availability for others. If you need the full dataset, obtain it from the FDA or rebuild it with the published source code, which is exactly what it is published for;
circumvent, disable or interfere with any security or access-control measure, or misrepresent the origin of the software.

6. Patient privacy

MAUDE narratives are redacted by the FDA before release under exemptions (b)(4) and (b)(6) of the Freedom of Information Act. Redaction is imperfect and identifying details occasionally survive in free text. If you encounter apparently identifying information, do not republish it, and report it to the FDA. Any attempt to re-identify individuals is prohibited under section 5 and may violate applicable law.

7. No warranty

MaudeDash is provided “as is”, without warranty of any kind, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, accuracy, completeness and non-infringement. Although the statistical implementations are tested and cross-validated against reference libraries, no assurance is given that the data, the calculations, or the availability of the service are free of error or interruption. You are responsible for independently verifying any figure before relying on it, publishing it, or acting on it.

8. Limitation of liability

To the maximum extent permitted by law, the author shall not be liable for any direct, indirect, incidental, special, consequential or exemplary damages arising from your use of, or inability to use, MaudeDash — including any decision, publication, clinical action or business outcome based on its output — even if advised of the possibility of such damages.

9. Availability and changes

MaudeDash is offered without any service-level commitment and may be modified, suspended or withdrawn at any time. The underlying dataset is refreshed periodically; the data vintage is displayed in the tool and in every generated methods paragraph, and you should record it alongside any figure you publish. These terms may be updated; the effective date above will change accordingly.

10. Citation

Citation is requested, not required. If MaudeDash contributed to published work, please cite the paper and state the data vintage — see the citation section.

11. Governing law

These terms are governed by the laws of the State of Ohio, United States, without regard to conflict-of-law principles. If any provision is held unenforceable, the remainder stays in effect.

12. Contact

Corrections, security reports and questions: open an issue on the source repository. For security specifically, see security.txt.