Investigation - as no details of the complaint were provided a thorough review of the device history records was performed to ensure the product met all product requirements and that there were no non conformances issued during the manufacture of the product in question.The review indicates that the product was manufactured properly and met all product requirements.Based on this review atrium medical can find no fault with the production lot of c-qur v-patch mesh in question.Clinical evaluation: atrium c-qur v-patch mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.Problems after mesh implantation are usually related to using a mesh product that is too small or to the fixation method and technique.It may also be related to non-compliance with activity limitations post operatively.Other factors that contribute to the outcome of mesh repairs are the patient's weight and medical comorbidities such as morbid obesity, diabetes and a history of smoking.The instructions for use (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs.
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