definiens: shall mean any oral, written or electronically transmitted report of any as defined by 21 C.F.R. 314.80, associated with the use of the Product, and the term shall mean any adverse drug experience occurring at any dose that resutts in any of the following outcomes : death, a life - threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, or congenital anomalylbirth defect . Important medical events that may not resutt in death, be life - threatening, or require hospitalization may be considered a serious adverse drug 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 outcomes listed in this definition . 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