Product complaint # (b)(4).(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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It was reported that a female patient underwent a knee surgery on (b)(6) 2017 and topical skin adhesive was used.On (b)(6) 2017 the patient developed a rash around the topical skin adhesive site and used peroxide for relief of itching.On (b)(6) 2017 the patient was prescribed keflex after reviewing wound, blister formation and bursting, itchiness.On (b)(6) 2018 the rash was resolved.Additional information was requested.
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