(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 is the procedure name and initial procedure date? incision of recurrent breast cancer (b)(6) 2018.How was the prineo applied on the mesh? as per instructions for use.What prep was used prior to product application? betadine.What was the location and incision size of the application? axilla - 8cm.Was a dressing placed over the incision? if so, what type of cover dressing used? no.What date did the reaction occur on? (b)(6) 2018.What does the reaction look like and how large of an area does the reaction cover? - unknown - was not viewed by surgeon.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Oral steroids and antihistamines.Can you identify the lot number of the product that was used? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.What is the most current patient status? satisfactory.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) - female patient, no pre-existing medical conditions.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.No.
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