2025 October FDA Received AMS 700 Adverse Events

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Attached - 2025 October FDA Received AMS 700 Adverse Events

Limited Mechanical Event Stats:
Only 41 out of 202 events had both event date and manufactured date
Assumption: 1 year of shelf life

Min: 2 months
Max: 12 yrs (Congratulations! 66 year old individual with LGX from South Korea. Event - Crack on pump connecting tube.)
Mean: 4 yrs
Median: 3 yrs

Sources:
-U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) Database.
https://www.accessdata.fda.gov/scripts/ ... search.cfm

Disclaimer: MAUDE data is a passive surveillance tool with reporting limitations and should not be interpreted for causality.