(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: please describe how the adhesive was applied on the tape - the incision was wiped down with water, and dried.Stratafix suture was used to close the subq.The surgeon typically uses 2 prineo with knee flexed.What prep was used prior to product application? unknown , but there has been no changes what date did the reaction occur on? 10-14 days.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify ¿ some patients were referred to dermatology.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.
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