It was reported that a pt underwent a surgical procedure for "total knee arthroplasty" on (b)(6) 2019 and prineo skin closing system was used.The pt developed a reaction to the product about 5 days after the procedure.The pt was reported and observed to have symptoms of redness, itching, and blisters to the skin directly adjacent to and around the prineo dressing.The topical skin adhesive was then removed.Antibiotics and local and systemic corticosteroids were given.Layer of sutures closed by the provider was combination of "#1 vicryl, 1 v-loc, 2-0 vicryl, 3-0 vicryl." the angle of the knee during surgery was reported as flexed and greater than 80 degrees.Preparation before prineo use was 2% chg wipes the night before surgery and the morning before along with chloraprep x 2 used to prep the extremity in the operating room.No patch or sensitivity tests performed.Fda safety report id# (b)(4).
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