Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.
D'ainneoin mhír 3, i gcás bás nó meath tromchúiseach gan choinne ar shláinte duine, cuirfear an tuairisc sin ar fáil láithreach tar éis don mhonaróir gaolmhaireacht chúise a shuíomh nó a luaithe atá drochamhras air go bhfuil gaolmhaireacht chúise idir an fheiste agus an teagmhas tromchúiseach, tráth nach déanaí ná 10 lá féilire tar éis an dáta ar a dtagann an monaróir ar an eolas faoin teagmhas tromchúiseach.