Serious adverse effect

{
  "id": "MLC-T-ENV-025274",
  "term": "Serious adverse effect",
  "field": "Environment",
  "term_source": "Serious Adverse Effect",
  "definition": "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; Hospitalization (initial or prolonged) .Disability or Permanent Damage; Congenital Anomaly/Birth Defect; Required Intervention to Prevent Permanent Impairment or Damage (Devices); Other Serious (Important Medical Events)",
  "subject": "Outcomes",
  "references": [
    "FDA What Is a Serious Adverse Event at http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm"
  ],
  "url": "https://mlchart.com/terminology/environment/serious-adverse-effect/"
}