Pari Montesol 177 Notice D'utilisation page 33

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  • FRANÇAIS, page 73
Reporting serious adverse events
Serious incidents which occur in connection with this
PARI product must be reported promptly to the manufacturer
and/or the distributor as well as to the competent authority.
Any event which has led or might lead directly or indirectly to
death or an unexpected serious worsening of the health condi-
tion of a person is to be considered serious.
Identifying and classifying warning instructions
Safety-critical warnings are categorised according to the follow-
ing hazard levels in these instructions for use:
DANGER
DANGER indicates a hazardous situation which will lead to
severe injuries or death if it is not avoided.
WARNING
WARNING indicates a hazardous situation which can lead to
severe injuries or death if it is not avoided.
CAUTION
CAUTION indicates a hazardous situation which can lead to
mild or moderate injuries if it is not avoided.
NOTE
NOTE indicates a situation which can lead to material dam-
age if it is not avoided.
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