MaudeDash
Publication-grade analytics over the U.S. FDA Manufacturer and User Facility
Device Experience database — running entirely in your browser.
Starting…
MaudeDash provides publication-grade analytics over the U.S. FDA Manufacturer and User Facility Device Experience (MAUDE) database, the FDA's passive surveillance system for medical device adverse events. Everything you see is computed in your browser: the host serves static data files and no query, filter or cohort definition is transmitted anywhere.
Patient outcomes are the FDA's own categories from
SEQUENCE_NUMBER_OUTCOME, dichotomised into the seven harms
defined by 21 CFR 803.3 — death, life-threatening, hospitalization,
disability, congenital anomaly, required intervention, and other — with a
composite "any serious" of D/L/H/S/C/R. Proportions carry Wilson 95%
confidence intervals. Group comparisons use Pearson's chi-square, with
Fisher's exact test when any cell falls below 10. Disproportionality uses
the proportional reporting ratio and reporting odds ratio with log-normal
95% intervals and a 0.5 continuity correction, alongside a Yates-corrected
chi-square; signals follow the EMA-2008 rule (PRR ≥ 2,
χ² ≥ 4, a ≥ 3). Trends use the Cochran-Armitage test
for trend in proportions and the tie-corrected Mann-Kendall test on yearly
counts. The statistics engine is cross-validated against SciPy to 1e-9 or
better on every function.
Editions: Browser and Research Edition · Paper: PubMed 42232423 · Source: github.com/mokshalstudios/MAUDE-DASH · Data: FDA MAUDE
Built by Mokshal Porwal · MIT License. MaudeDash is an independent research tool. It is not affiliated with, endorsed by, or reviewed by the U.S. Food and Drug Administration.