definiens: means any adverse reaction associated with the use of Productin humans ( as defined below ), whether or not considered product related and whether or not confirmed by a healthprofessional . is not limited to a causal relationship of the reportedevent to Product, and may include ( i ) an Adverse Event occurring in the course of the use of Product in professionalpractice, ( ii ) an Adverse Event occurring from abuse of Product, ( iii ) an Adverse Event occur ring from the withdrawalof Product, or ( iv ) any significant failure of expected action . means a claim or expression ofdispleasure, dissatisfaction or annoyance with Product, Product - related materials or Product - related info1mation . AProduct Complaint may or may not involve a formal charge or accusation . A Product Complaint may be related to, among other things, identity, purity, potency, safety or quality of Product . Notwithstanding the definition of ProductComplaint, if the complaint involves a medical event in a patient, it is regarded as an Adverse Event