Was some kind of intervention required in order to prevent permanent imparement or damage as an outcome attributed to the Adverse Event (used only when the product is a medical device)? Note that this property is not in ICH, nor is it used in VAERS, because neither ICH nor VAERS are concerned with devices.
MedWatch 3500 form question B.2, box 4.
MedWatch 3500A form question B.2, box 4.
MedWatch 3500B form question A.2, box 2.