(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: how was the device applied to the incision ¿ proximal to distal, uses 2 prineo and overlap by ½¿ ¿ second one is used because of the hyperflexing; no tension; lets dry, wraps knee what prep was used prior to product application? unknown what was the location and incision size of the application? see photo was a dressing placed over the incision? if so, what type of cover dressing used? sometimes 2 x 4.Please explain how the skin layers were closed to reduce skin tension? capsule is closed with interrupted 1-0, 2-0 vicryl suture; skin 3-0 monocryl to close dermis can you identify the lot number of the product that was used? unknown is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.What is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) : unknown - full spectrum of patients.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.
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