Comment from Anonymous
AnonymousOpposeIndividual
Summary: The commenter opposes the citizen petition, arguing that the FDA advises against using MAUDE data for trend analysis due to its limitations as a passive surveillance system. They also state that relevant incidents can already be easily found using the existing FDA MAUDE database search tool.
I do not support this petition for two reasons:
1) The FDA advises against any trend analysis. Quoting two selected sentences from the FDA MAUDE website (https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude-database):
See section:
Limitations of Medical Device Reports (MDRs)
"MDR data is not intended to be used either to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices."
"In addition, although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use."
2) It is easy with the existing FDA MAUDE database search tool to find the other "MRI" or "magnetic resonance" incidents