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

  • 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.

  • Paper VAS sheetsTherapy PeriodFor Control and Treatment Groups: Confirm Inclusion/Exclusion criteria continues to be met, collect blood pressure, AEs, and review Adverse Device Events, paper diary (dispense additional diaries), weight, blood pressure, assess for AE’s/concomitant medications, completion of hunger and Completion of TFEQ- R18V2, encourage continuation of low-calorie diet at each scheduled visit.

  • 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).

  • 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.

  • Separate data listings will be presented for all AEs and SAEs. Unanticipated Adverse Device Events (UADE) A UADE is defined as any AE that is definitely related to the study device.

  • When Unanticipated Problems Involving Risks to Subjects or Others or Unanticipated Adverse Device Events are reported to the IRB, and the IRB agrees that they fall into these categories, then the IRB notifies the institution about these events, and the institution notifies FDA and OHRP (as applicable) that these unanticipated problems have occurred when the studies are under their oversight.

  • Federal guidelines do not require reporting adverse events to IRBs. They do require that Unanticipated Problems Involving Risks to Subjects or Others [21 CFR 56.108(b)] and Unanticipated Adverse Device Events [21 CFR 812.150(a)(1)] be reported to the IRB [45 CFR 46.103(b)(5)].

  • Adverse effects that occurred in the PMA clinical 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.

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

  • Specifically, a responder must attain ≥50% pain reduction in ≥50% of the treatment sessions during the Randomized Testing phase of the study (through Month 3).The study’s primary safety endpoint is the incidence of all serious adverse events, including Serious Adverse Events (SAEs), Serious Adverse Device Events (SADEs), and Unanticipated (Serious) Adverse Device Events (UADE), from the time of injection through three months post- implant.

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 any decision by a review agent not to certify an admission,

  • Milestone Events has the meaning set forth in Section 7.2.

  • Co-occurring disorder specialist means an individual

  • 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.

  • Effective Technological Measures means those measures that, in the absence of proper authority, may not be circumvented under laws fulfilling obligations under Article 11 of the WIPO Copyright Treaty adopted on December 20, 1996, and/or similar international agreements.

  • 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, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Biologically-based mental illness means schizophrenia, schizoaffective disorder, major depressive disorder, bipolar disorder, paranoia and other psychotic disorders, obsessive-compulsive disorder, and panic disorder, as these terms are defined in the most recent edition of the diagnostic and statistical manual of mental disorders published by the American Psychiatric Association.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • 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.

  • Autism spectrum disorders means any of the pervasive developmental disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, published by the American Psychiatric Association, including autistic disorder, Asperger's disorder and pervasive developmental disorder not otherwise specified.

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

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

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • 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 a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • COVID-19 test means a viral test for SARS-CoV-2 that is:

  • 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.

  • Diagnostic mammography means a method of screening that

  • 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.