Adverse Device Events definition

Adverse Device Events means any Product-related event that is reportable (or that Purchaser or Manufacturer determines after Best Efforts at mutual consultation should be reported) to (i) the FDA, or any local ethics committee ("LEC") responsible for approving the protocols for any clinical trials) conducted upon the Products in the Territory or any other ethics committee within the Territory with responsibilities analogous to a LEC; or (ii) to any other Governmental Authority responsible for the regulation of medical devices.
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Examples of Adverse Device Events in a sentence

  • There were no Serious Adverse Device Events (SADEs) or Unanticipated Adverse Device Effects (UADEs) reported during either of the clinical studies (G110131/A001 and G100028).

  • CISGIL is entitled to frame its claim as one for wasted expenditure but that simply represents a different method of quantifying the loss of the bargain; it does not change the characteristics of the losses for which compensation is sought.684.

  • Safety data of the System were also collected and characterized by the incidence and severity of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study subjects.

  • Adverse Events (AEs), including Serious Adverse Events (SAEs); and Adverse Device Events (ADEs), including Serious Adverse Device Events (SADEs).

  • Adverse effects that occurred in the Guardian sensor study: The safety of the Guardian Sensor was assessed by evaluation of the incidence of all adverse events, Adverse Device Effects (ADEs), Serious Adverse Device Events (SADEs), and Unanticipated Adverse Device Effects (UADEs) experienced by study subjects.

  • Adverse events that occurred in the pivotal study: The safety data of the 670G System was assessed by evaluation of the incidence of all serious Adverse Events, Adverse Device Effects (ADEs), Serious Adverse Device Events (SADEs), and Unanticipated Adverse Device Effects (UADEs) experienced by study subjects.

  • There were no Unanticipated Serious Adverse Device Events, Serious Adverse Device Events, Non-Serious Adverse Device Events, or Device- System Related Complications.

  • Standardized date formats on medical device labels would eliminate any possibility of confusion from date formats that might be interpreted in more than one way.Improved Postmarket Adverse Device Events Reporting and Device Recalls The final rule is expected to improve adverse medical device event reporting by providing a reliable and unique identifier with which to report a problem device.

  • The safety of the device was assessed by evaluating the incidence of all serious Adverse Events (AEs), Adverse Device Events (ADEs), Serious Adverse Device Events (SADEs), and Unanticipated Adverse Device Effects (UADEs) experienced by study subjects.

  • Assessment of safety:To assess safety of study device use, all Serious Adverse Events, Unanticipated Adverse Device Events and Device Related Adverse Events will be recorded and compared between therapy groups...

Related to Adverse Device Events

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Adverse determination shall have the meaning set forth in Section 19.7.

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Adverse decision means a decision reducing,

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Final Adverse Determination means an Adverse Determination involving a Covered Service that has been upheld by Blue Cross and Blue Shield or its designated utilization review organization, at the completion of Blue Cross and Blue Shield's internal grievance process procedures.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Friable asbestos material means any material that contains more than 1% asbestos by weight and that can be crumbled, pulverized, or reduced to powder when dry, by hand pressure.