any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible;
aon tarlú díobhálach tromchúiseach a bhfuil gaolmhaireacht chúise aige leis an bhfeiste, leis an gcomparadóir nó leis an nós imeachta staidéir nó i gcás ina bhféadfadh gaolmhaireacht chúise den sórt sin a bheith ann go réasúnach;