Adverse drug event

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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)

Important interactions

References

  1. What is a Serious Adverse Event? FDA. [1]