Investigation: a review of the lot history and sterilization records was conducted.No deviations were noted or found in any of the documentation and all release criteria was met, including testing for suture retention (coarse and wale), fourier-transform infrared spectrophotometry (ftir),release criteria and sterilization records.This lot met all manufacturing and quality release criteria including ftir of mesh, suture and ball burst, stitch strength and pouch peel specifications prior to sending to the sterilizer.The sterilization record review passed all acceptance criteria.Medical record review: a review of limited medical records reveal that the mesh was explanted due to a suspicion of a chronically infected mesh.Cultures revealed no bacterial growth, either aerobic or anaerobic.Clinical evaluation: microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound.Infections may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.Inflammation is the biological response to something harmful or irritating that affects a part of our body.The signs and symptoms of inflammation, specifically acute inflammation, show that the body is trying to heal itself.Inflammation does not mean infection, even when an infection causes inflammation.Infection is caused by a bacterium, virus or fungus, while inflammation is the body's response to it.The instructions for use precaution against handling of the mesh without clean sterile gloves and instruments.It states in adverse reactions, "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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