Adverse event or incident relating to a medical device definition

Adverse event or incident relating to a medical device means any malfunction of the medical device, performance failures, absence or impaired efficacy of the medical device, inadequacy of the effects of the medical device, including any deficiencies in labelling, instructions or packaging, where these adverse events lead or might have led to a death or a serious deterioration in health of the patient, user or third party.
View Source
Adverse event or incident relating to a medical device means any defect, loss of value of its properties, absent or reduced efficacy of a medical device, adverse reaction of a medical device, as well as any inaccuracy in its labelling or instructions for use, where this adverse event lead or might have led to death or a serious deterioration in health of the patient, user or a third party.
View Source

Related to Adverse event or incident relating to a medical device

  • Law relating to a public servant s office or employment” means a law that specifically applies to a person acting in the capacity of a public servant and that directly or indirectly imposes a duty on the public servant or governs the conduct of the public servant. Penal Code 39.01(1)

  • Complex or chronic medical condition means a physical,

  • Statement of Grievance shall name the employee involved, shall state the facts giving rise to the grievance, shall identify by appropriate reference all the provisions of this Master Contract alleged to be violated, shall state the contention of the employee and of the Association with respect to these provisions, and shall indicate the specific relief requested.

  • Imminent danger to the health and safety of the public means the existence of any condition or practice, or any violation of a permit or other requirement of this article, in a surface coal mining and reclamation operation which could reasonably be expected to cause substantial physical harm to persons outside the permit area before such condition, practice, or violation can be abated. A reasonable expectation of death or serious injury before abatement exists if a rational person, subjected to the same conditions, or practices giving rise to the peril, would not expose himself to the danger during the time necessary for abatement.

  • Attack directed against any civilian population means a course of conduct involving the multiple commission of acts referred to in paragraph 1 against any civilian population, pursuant to or in furtherance of a State or organizational policy to commit such attack;