Feedback of suspicious adverse events / reactions

*Source of report

Operating enterprises

medical institution

other

Contact address

organization

Postal Code contact number

A-Patient information

*Name *Age *Sex

male

female

*Intended to treat a disease or effect

B- Adverse events / reactions

*Main performance of the event

*Date of occurrence

Y / M / D

*Discover or know the time

Y / M / D

*Actual use place

medical institution

family

Others (please specify):

*Consequences of the incident

death （time）

Life threatening

Permanent damage of body function and structure

It may cause permanent damage to the body's functional mechanism

Internal and surgical treatment is needed to avoid the permanent injury

Others (as stated in event statement)

*Statement of events：

（At least including the time of use, the purpose of use, the basis of use, the situation of use, the adverse events, the impact on the victims, the treatment measures taken, and the combined use of the devices.）

*Reporter

doctor

technician

nurse

other

*contacts *contact number

C-Products involved

*Product name

*Registration Certificate No

Enterprise telephone

*Model and specification

*Operator

professional

Non professionals

Others (please specify)

*Valid until

Y / M / D

*Stop date

Y / M / D

Trade name

*Name of manufacturer

Address of manufacturer

*Product number

*Product batch number

*date of manufacture

Y / M / D

*Date of use

Y / M / D

*Preliminary cause analysis of the incident

*Preliminary handling of the incident *Event report status

The user has been informed

The manufacturer has been informed

he operating enterprise has been informed

The drug administration has been informed

other