The lot history was reviewed.Incoming inspection records show the bare mesh used to manufacture this lot passed all suture and ball burst strength requirements.This lot passed incoming inspection, including fourier-transform infrared spectrophotometry (ftir) testing.The qc in-process testing completed for each sub-assembly met all release criteria including visual inspection, ftir, pouch peel and stitch strength analysis.Records show that the lot was sterilized acceptably.Based on the available lot information, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture.Clinical evaluation: any surgery that causes a break in the skin can lead to a postoperative infection.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.Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling.Other risks for infection include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes.The ifu 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.
|