Common use of Product Complaints Clause in Contracts

Product Complaints. Distributor agrees to use its reasonable efforts to promptly report to Supplier all available information concerning any product complaints not related to death or serious injury that it is aware of. This information will be reported to assist Supplier in monitoring the quality and safety of its Products, and to allow Supplier to meet its reporting obligations under the United States Medical Device Reporting regulations (21 CFR 803.1 et seq.) and Medical Device Vigilance Guidelines, if applicable. Information concerning such product complaints may be reported to the Supplier either verbally or in writing. A “product complaint’ is any written or oral expression of dissatisfaction as to the identity, quality, durability, reliability, safety, effectiveness, or performance of a Product. Product complaints associated with a death or serious injury, or a malfunction that could reasonably be expected to result in a death or serious injury if the malfunction recurs, or any adverse event relating to a Product, will be reported to Supplier immediately upon Distributor’s knowledge of that information.