Adverse Event. Any untoward medical occurrence in a patient, clinical investigation subject, user or other person administered a pharmaceutical product, or after use of a cosmetic product or medical device, and which does not necessarily have a causal relationship (association) with this treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the product, whether or not related to the product. Complaint: Any report received (written, electronic or verbal communication) about a potential or alleged failure of a product in its quality (including the identity, durability, reliability, safety, efficacy, or performance) or a suspected counterfeit. The complaint may or may not represent a potential risk to the patient/customer/user/environment
Adverse Event. The occurrence of an Adverse Event.
Adverse Event. Any untoward medical occurrence in a patient or clinical investigation subject or consumer, temporally associated with the use of the Suppliers product, whether or not considered related to the product.
Adverse Event. The Vendor must notify the State contact within three days if the Vendor becomes aware that an Adverse Event has occurred. An Adverse Event is the unauthorized use of system privileges, unauthorized access to State Data, execution of malware, physical intrusions and electronic intrusions that may include network, applications, servers, workstations, and social engineering of staff. If the Adverse Event was the result of the Vendor’s actions or inactions, the State can require a risk assessment of the Vendor the State mandating the methodology to be used as well as the scope. At the State’s discretion a risk assessment may be performed by a third party at the Vendor’s expense. State Data is any data produced or provided by the State as well as any data produced or provided for the State by a third-party.
Adverse Event. This Agreement and the Plan of Arrangement may be terminated if an Adverse Event occurs. "
Adverse Event any circumstance, event, or condition resulting from either action or inaction that:
a) Was undesirable and unintended; and
b) Did not result in any serious harm to a member’s health, safety or well-being; and
c) Indicates or may indicate a quality issue with the services provided by the MCO or any of its providers.
Adverse Event. The Lender shall have determined in good faith (which determination shall be conclusive) that (i) an Adverse Event has occurred or (ii) the Lender's interest in any material Collateral or Third Party Collateral has been adversely affected or impaired, or the value thereof to the Lender has been diminished to a material extent, or (iii) the prospect of payment or performance of any obligation or agreement of the Borrower or any other Obligor under any of the Loan Documents is materially impaired, and the condition giving rise to such determination does not constitute an Event of Default under any of the other subsections of this SECTION 7.1; and
Adverse Event. Any adverse events, device malfunctions or quality complaints related to the Receiver products should be dealt in accordance with local legal requirements. Service Provider shall forward to the Receiver’s local vigilance representative, any vigilance related information, as soon as possible, at the Receiver’s address listed in the Service Agreement. In case the Service Provider is conducting Market research activities for the Receiver, the Service Provider is required to comply with the terms in Exhibit 1. In case the Service Provider is involved in the activities of handling, posting, reposting on Social Media on behalf of the Receiver, then the Service Provider is required to comply with the terms in Exhibit 2. Adverse Event (AE) is any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product/ Alcon Medical Device and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A complaint is any oral, electronic, or written communication that alleges deficiencies related to the identity (labelling), quality, durability, reliability, safety, effectiveness, or performance of a marketed product, including failure of the product, labelling or packaging to meet specifications, whether or not the product is related to or caused the alleged deficiency. Examples of product/device complaints include but are not limited to: Product dissatisfaction, Torn contact lenses, Lenses filmy, product not cleaning lenses, Broken haptic on an intraocular lens etc.
Adverse Event. Any untoward medical occurrence in a patient during the use of a medical device. Becomes Aware—according to 21CFR803: Manufacturer “Becomes aware” of a MDR reportable event when (1) any employee becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days pursuant to a written request from FDA; and (2) any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable event, from any information, including any trend analysis, necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. Caused or Contributed — according to 21CFR803: Means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: failure – malfunction – improper or inadequate design – manufacture – labeling – user error. Complaint: Means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Adverse Event. As soon as the Borrower becomes aware of it, notice of any adverse event or condition affecting the Borrower or the Facility, including (i) any Default or Default Event, (ii) any material casualty loss or other damage to the Facility, (iii) any breach, actual or alleged, termination or nonrenewal of the Supply Agreement, and (iv) any representation or warranty in the Loan Documents being incorrect or inaccurate in any material respect.
