Reading a safety statement: what "no adverse events reported" establishes
Two phrases turn up constantly in device marketing and they look interchangeable. They are not. One is a reportable observation with a defined meaning; the other is a claim about the future that no finite amount of data can support. Keeping them apart is one of the cheapest ways to make a technical document more credible, so it is worth setting out the difference properly. What an adverse event actually is In regulatory usage, an adverse event is any untoward medical occurrence in a person who has received the treatment under study, whether or not it is judged to be caused by that treatment. The definition is deliberately wide, and the causal question is handled separately, afterwards, by assessment. That last point is the one most often lost. “Adverse event” is not a synonym for “harm done by the device.” It is the raw observation, before anybody has decided what caused it. Narrowing the definition at collection time — only writing down what looks d...