May 2025 - IPP Adverse Event Reports

[Kodixx]

I still think you have to consider the different between an "Event Type" of "Malfunction" versus "Injury". I'm sure the data isn't perfect, but its the difference between a count of 200+ versus 14.

- Chuck

[Discovernew]

I still think you have to consider the different between an "Event Type" of "Malfunction" versus "Injury". I'm sure the data isn't perfect, but its the difference between a count of 200+ versus 14.

- Chuck

Hi Chuck, what do you mean by "injury"? In the details is showing "injury" as a tubing leak for example, you can read each one of the cases on its own.

The important thing is that over 200 implants needed to be replaced.

[tooyoung]

I still think you have to consider the different between an "Event Type" of "Malfunction" versus "Injury". I'm sure the data isn't perfect, but its the difference between a count of 200+ versus 14.

- Chuck

Almost all reports categoried as "injuries" are malfunctions...see in the descripton...it's just a misnomer.

[Kodixx]

Discovernew & tooyoung, well, my bad. When I had the Event Type filter set to Injury only, I read a couple related to problems from bad surgery and/or some kind of physical event. But I just went back and read a lot more, and realize they should have been coded as Malfunction instead of Injury.
Again, mea culpa.

- Chuck

Hi Chuck, what do you mean by "injury"? In the details is showing "injury" as a tubing leak for example, you can read each one of the cases on its own.

[LastHope]

I didn't know such info was available.

Where did you find it? Is this USA-Only?

Based on this report, the majority of malfunctions are Titans (68%).

https://www.accessdata.fda.gov/scripts/ ... search.cfm

I ran a search above for May 2025. I don't think this is USA only. I've seen some reports from Brazil, Canada and Korea as well. Here's an example from Brazil.

https://www.accessdata.fda.gov/scripts/ ... uence_no=1

Thanks. I get the impression that this is a U.S.only thing. First of all, the FDA is a US institution. No other country is required to report to them. And the only brands included in the report are AMS and Coloplast. No Rigicon at all which is popular in other countries

You're right, Discovernew.

Even if few reports are submitted from Korea, Brazil, Canada....I see none from UK, India, Egypt, Australia.....hospitals outside the US are not legally obligated to report adverse events the way US hospitals are by the FDA. So treating this as US based data seems more accurate.

I'm personally interested in Rigicon Infla 10 data, which is still awaiting FDA approval. Once it's approved, I expect adverse events (if any) to appear in the database, since Rigicon is headquartered in Ronkonkoma, New York.