Life-threatening means that the subject was at immediate risk of death from the AE as it occurred or it is suspected that use or continued use of the product would result in the subject’s death. ‘Life-threatening’ does not mean that had an AE occurred in a more severe form it might have caused death (eg, hepatitis that resolved without hepatic failure).
Bodily injury means bodily injury, sickness or disease sustained by a person, including death resulting from any of these at any time.
Serious bodily injury means bodily injury which involves a substantial risk of death, extreme physical pain, protracted obvious disfigurement or protracted loss or impairment of the function of a bodily member, organ or mental faculty.
Intimidating, threatening, abusive, or harming conduct means, but is not limited to, conduct that does the following:
Serious injury or illness means an Injury or Illness incurred in the line of duty that may render the member of the Armed Forces medically unfit to perform his or her military duties.
Severe property damage means substantial physical damage to property, damage to the treatment facilities which would cause them to become inoperable, or substantial and permanent loss of natural resources which can reasonably be expected to occur in the absence of a bypass. Severe property damage does not mean economic loss caused by delays in production.
Property damage means physical injury to, de- struction of, or loss of use of tangible property.
Disease means an alteration in the state of the body or of some of its organs, interrupting or disturbing the performance of the functions, and causing or threatening pain and weakness or physical or mental disorder and certified by a Medical Practitioner.
Accident means a sudden, unforeseen and involuntary event caused by external, visible and violent means.
Injury means accidental physical bodily harm excluding illness or disease solely and directly caused by external, violent and visible and evident means which is verified and certified by a Medical Practitioner.