Difference between revisions of "Adverse drug event"
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(Created page with "'''An adverse event''' is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patien...") |
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Revision as of 18:30, 17 November 2011
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:
Death Life-threatening Congenital Anomaly/Birth Defect Required Intervention to Prevent Permanent Impairment or Damage (Devices) Other Serious (Important Medical Events)
References
- What is a Serious Adverse Event? FDA. [1]
