It never occurred to me that encouraging people to voluntarily participate in improving their own lives and the lives of others who share their disease through civic action would be a subject for debate.
I was raised to believe that if knew of a problem, a defect, but did nothing about it and allowed other people to suffer as a consequence, I became part of that problem.
Others here may not agree with that worldview, but I firmly believe that encouraging people to not participate in solving problems is destructive. We’re seeing the consequences of “it’s not my problem” on a scale previously unheard of.
If people here are not clear on what an adverse effect is, an adverse effect is anything that could produce a negative effect on health with the most serious requiring emergency treatment.
What the FDA is interested in is whether anything that it has a responsibility for regulating, including medical devices used by consumers, has any characteristics that makes them unreliable or unsafe for that application. If adverse effects aren’t reported the FDA doesn’t know that there’s a problem.
Adverse effects have causes. If they aren’t reported those causes aren’t addressed. it doesn’t matter whether they are due to operator errors, bad device interfaces, alerts that are confusing or not audible, difficulty in using a device, inaccuracy or unreliability.
If anything about a device you used could have predictably threatened your health, whether a medically necessary device failed and a replacement was not unavailable, if you needed or you only avoided hospitalization by taking emergency measures yourself, it should be reported.
If it happened to you, it’s going to happen to somebody else and they might not be as competent or lucky in dealing with that situation as you were.
The FDA does not forward information on the identity of a person filing a report to physicians or care providers and the form that’s used can make your identity anonymous to the company that makes the device.
You won’t get credit for it and you won’t get blamed for it. If it seems like too much work then I don’t know what to say. I believe it’s a small cost to live in a civilization.
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm