Product complaint # (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.The following additional information was provided: were the antihistamine or hydrocortisone cream prescribed? yes.Did the patient experience a post-op device malfunction? --> no.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> unknown.Did the patient require revision surgery or hardware removal? --> no.Patient status/ outcome / consequences --> yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> a rash appeared in the location where the prineo was placed.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no.Is the patient part of a clinical study --> unknown.(b)(4).Device property of -->none.Device in possession of -->none.Attempts are being made to obtain the following information.However, no further information is available: what is initial procedure date? what date did the reaction occur on? do you have any pictures of the reaction? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.What is the most current patient status? can you identify the lot number of the product that was used?.
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It was reported that a patient underwent a total knee replacement procedure on an unknown date and topical skin adhesive was used.The patient developed a latent rash reaction approximately 4-6 weeks after surgery, in the same location where the topical skin adhesive was placed.The topical skin adhesive had sloughed off or had been removed, but in that location, rash-like vesicles were seen.The reaction spreads a bit throughout the leg.The rash resolved on its own within about a week and did not require any major intervention other than antihistamine and hydrocortisone cream.There has been no change in patient prep nor their pre-op medications.Additional information has been requested.
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