![horizontal rule](https://webarchive.library.unt.edu/eot2008/20090120034617im_/http://www.fda.gov/medwatch/images/brokspec.gif)
Clinical Impact of Adverse Event Reporting
TABLE 1-MedWatch: What is a Serious Event?
Any event that ...
- is fatal
- is life-threatening
- is permanently/significantly disabling
- requires or prolongs hospitalization
- causes a congenital anomaly
- requires intervention to prevent permanent impairment or damage
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