Is a untoward medical occurrence
Can occur In a patient administered a medicinal product or in a consumer having used or using a C-P product
Does not necessarily have to have a causal relationship with this treatment or use
All of the above
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Life- threatening incident needing medical intervention or even prolongs hospitalization / Death
Persistent or significant disability / incapacity / Congenital anomaly / birth defect
Requires intervention to prevent one of the above
All of the above
1 day of occurence
2 days of occurence
1 week of occurence
1 month of occurence
1 day of occurence
2 days of occurence
7 days of occurence
1 month of occurence
Pateint
Reporter
Product
All of the above
A Must Do for everyone
Good to for everyone
Not compulsory for everyone
Not my responsibility
Complete form 11330
Inform my Manager and Local subsidiary Communications team
Withold the information
Both a & b
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