(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: what prep was used prior to product application? hibiclens scrub and duraprep.What date did the reaction occur on? patients range from 1-6 weeks post-op before the rash is noticeable.What does the reaction look like and how large of an area does the reaction cover? the rash looks like small, red, blister bumps.Very itchy.It typically appears on the anterior knee surrounding the incisions.Was there any medical or surgical intervention performed? hydrocortisone cream to be applied 2-3 times per day, benadryl tabs as needed, & ice the area.Was the hydrocortisone cream used on the patient prescribed? prescribed were the benadryl tabs used on the patient prescribed? patient was encouraged to take otc benadryl as directed on the bottle.What was the outcome of the two patients who were referred to a dermatologist? one of the tka¿s was dx¿d with a hypersensitivity reaction & given triamcinolone 0.1% bid for 2-3 weeks.The tibial orif was dx¿d with allergic contact dermatitis/skin infection.Given cephalexin 250mg tid for 10 days & triamcinolone 0.1% bid for 2-3 weeks.
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It was reported that a patient underwent a knee arthroplasty procedure on an unknown date and topical skin adhesive was used.Post operatively, one to six weeks post op the patient experienced a skin rash reaction around the topical skin adhesive site.The rash appears on the anterior knee surrounding the incisions and looks like small, red, blister bumps and itchy.The patient was treated with hydrocortisone cream, applied 2-3 times per day, benadryl tabs as needed and iced the area.Additional information has been requested.
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