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. 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.
2025 October FDA Received AMS 700 Adverse Events
-
lasthope2.0
- Posts: 56
- Joined: Sat Oct 11, 2025 1:23 pm
2025 October FDA Received AMS 700 Adverse Events
You do not have the required permissions to view the files attached to this post.
40, 2024 - Coloplast Genesis malleable 22cm-13mm with 1cm RTE. Subcoronal. Considering an IPP.
Who is online
Users browsing this forum: ClaudeBot, Facebook, Google [Bot] and 50 guests
