How to write a summary analysis and evaluation report of medical device adverse events

According to the "on the issuance of medical device adverse event monitoring and re-evaluation management approach (for trial implementation) notice"

Article XII of the medical device manufacturers, business enterprises and the use of units found or aware of should be reported adverse events of medical devices, should fill out the "Suspected Medical Device Adverse Event Reporting Form" (Annex 1) to the location of the provinces, autonomous regions and municipalities directly under the Central Government of the adverse events of medical devices Monitoring technical organizations to report. Among them, the events leading to death within 5 working days from the date of discovery or knowledge, leading to serious injury, may lead to serious injury or death within 15 working days from the date of discovery or knowledge of the report.