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The FDA's Front Door - Page 2

© Adelle Vancil Tilton

Life-threatening: Check if suspected that: a)The patient was at substantial risk of dying at the time of the adverse event or b) Use or continued use of the device or other medical product might have resulted in the death of the patient.

Hospitalization (initial or prolonged): Check if admission to the hospital or prolongation of hospitalization was a result of the adverse event. DO NOT check if a patient in the hospital received a medical product and subsequently developed an otherwise nonserious adverse event, UNLESS the adverse event prolonged the hospital stay. DO check if: a) A patient is admitted to the hospital for one or more days, even if released on the same day or b) An emergency room visit results in admission to the hospital. Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage.)

Disability: Check if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions. Such would be the case if the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life.

Congenital anomaly: Check if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.

Required intervention to prevent permanent impairment or damage: Check if you believe that medical or surgical intervention was necessary to: a) Preclude permanent impairment of a body function or b) Prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.

Drugs and Biologics: This box should be checked for important medical events that may be considered a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the other serious outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. (In other words, a medication that causes a patient to break out in hives or results in a physical or psychological dependency, does not merit a report. - Italics mine)

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