a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established;
aon fhógra a thugtar don úsáideoir agus/nó don othar go bhfuil teagmhas tromchúiseach a bhaineann leis an bhfeiste tar éis titim amach, ba cheart é a thuairisciú don mhonaróir agus d'údarás inniúil an Bhallstáit ina bhfuil an t-úsáideoir agus an t-othar lonnaithe;