Comment from Tobias Gilk
AnonymousSupportIndividual
Summary: The commenter is responding to an anonymous comment regarding a citizen petition by Tobias Gilk. They argue in support of the petition by explaining that the proposed action is for identifying acute concerns rather than trend analysis and highlighting the limitations of the current FDA MAUDE database search tools.
Responding to Anonymous comment FDA-2025-P-3439-0015:
"The FDA advises against any trend analysis"
The petition does not describe a longitudinal or trend usage, but rather an immediate usage for the identification of acute concerns.
"It is easy with the existing FDA MAUDE database search tool to find the other "MRI" or "magnetic resonance" incidents"
Within the "advanced search" online MAUDE tool, one can not perform a text-search, as suggested by the commenter. Within the "simple search" online MAUDE tool one can perform a text-search, but in searching for the text string "MRI" for calendar year 2025 (with AE's only through August), the result produces in excess of 500 adverse event reports (the maximum returnable via the online tool), omitting results from review / analysis. It is possible under "simple search" to combine "MRI" with another product code, but this will fail to return references that fully spell-out magnetic resonance imaging, for example, and will include incidents which only coincidently mention MRI and not limit the listings to those with suspected causal relationship.