May 2025 - IPP Adverse Event Reports

[Discovernew]

Thanks! Didn't know this existed. Found my infection report from March. I'm famous!

Which one exactly is your infection? and how do you know its yours and not someone else?

[Courage]

Thanks! Didn't know this existed. Found my infection report from March. I'm famous!

Which one exactly is your infection? and how do you know its yours and not someone else?

Looking at the printout the one I thought was mine was not. I looked in the simplified Maude search for "IPP infection.". Can't find mine--it's not a simple database to search.

[Discovernew]

Thanks! Didn't know this existed. Found my infection report from March. I'm famous!

Which one exactly is your infection? and how do you know its yours and not someone else?

Looking at the printout the one I thought was mine was not. I looked in the simplified Maude search for "IPP infection.". Can't find mine--it's not a simple database to search.

Courage, how is your opinion about your malleable? Is it good to have sex or you hate it?

[ready2go]

AussieGuy81, maybe -- but when I set the filter to "Malfunction" only, and exclude "Injury", for "Event Type", I only count 14.

- Chuck

That's pretty crazy, over 200 incidents where basically they all had to be removed

so if you cover one eye and look to the side ,you will not see that, 200 HAD TO BE REMOVED, and you will not see the monster under the bed either . got it .

[Discovernew]

AussieGuy81, maybe -- but when I set the filter to "Malfunction" only, and exclude "Injury", for "Event Type", I only count 14.

- Chuck

That's pretty crazy, over 200 incidents where basically they all had to be removed

so if you cover one eye and look to the side ,you will not see that, 200 HAD TO BE REMOVED, and you will not see the monster under the bed either . got it .

I wonder how many ipps are installed in 1 month in USA? To get an idea of what % fails on average.

[Discovernew]

The file has 219 failures which I assume are for 1 month.

It is estimated that between 20000 and 25000 ipps are installed per year in USA. This would be roughly 1600 per month.

A rough estimate would be a 13% failure. Just a rough calculation.

https://auanews.net/issues/articles/202 ... perplexity

[tooyoung]

The file has 219 failures which I assume are for 1 month.

It is estimated that between 20000 and 25000 ipps are installed per year in USA. This would be roughly 1600 per month.

A rough estimate would be a 13% failure. Just a rough calculation.

https://auanews.net/issues/articles/202 ... perplexity

There are two contingents to this yearly estimate..1)number of ipps installed yearly is not inflated.
2)all or atleast most of failures are reported.

I doubt these two are achieved...I think by big fucking gaps...However, yearly 13% failure rate is still more reasonable than perito's 1% or the other con-artists'.

[LastHope]

what is the website to go to so I can check back and see if my issues have been noted on this list?

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

It's called the MAUDE database by the FDA.
MAUDE - Manufacturer and User Facility Device Experience

For all FDA regulated medical devices, hospitals, manufacturers (device reps) and even importers abroad are required by FDA to submit reports of all malfunctions. This database is updated on a monthly basis.

Easymoney, I see no reports of Rigicon devices in this database.

[LastHope]

I've attached the adverse events reported by surgeons to the FDA for IPPs in the month of May. The file can be viewed in Excel or Google Sheets.

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

[Discovernew]

I've attached the adverse events reported by surgeons to the FDA for IPPs in the month of May. The file can be viewed in Excel or Google Sheets.

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