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