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Product complaint (b)(4).Date sent to fda: (b)(6) 2018.(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 dermabond applied? dermabond liquid was applied in a thin layer on top of the skin(for dnx12) and on top to the tape(for clr602us).Excess liquid is wiped off the patient¿s skin.What layer of tissue was the demrabond applied to? dermabond was applied to the epidermis of the patient(for dnx12) and on top of the tape(for clr602us).How many layers of dermabond were applied? one.What prep was used prior to product application? chloroprep.What was the location and incision size of the application? on (b)(6) 2018 case, location is periareolar(breasts) and panniculectomy incision(lower abdomen).Was a dressing placed over the incision? if so, what type of cover dressing used? no dressings on small incisions.Large abdominal incisions sometimes get abdominal binders.What date did the reaction occur on? on (b)(6) 2018.What does the reaction look like and how large of an area does the reaction cover? the patient developed a rash and the skin became inflamed.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.For (b)(6) 2018 case, the patient was sent to the dermatologist on (b)(6) 2018.The dermatologist diagnosed this patient as having ¿allergic dermatitis with a secondary bacterial infection¿.Can you identify the product code and lot number of the product that was used? codes were (b)(4).No lot numbers were recorded.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not certain if patient is allergic to the aforementioned.If the patient is female, please ask if they were exposed to similar products, such as artificial nails? will follow up with surgeon and pa.What is the most current patient status? for the (b)(6) 2018 patient, she is still being treated by the dermatologist.Patient demographics: female.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? will follow up with surgeon and pa.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Do you have photos for the patient procedure date (b)(6) and patient procedure date (b)(6)? do you have event dates or details for any additional patient events? please describe where the dermabond and prineo 60 were used on each patient? where specifically was the prineo 60 used on the patient? where was the dnx12 used on the patient?.
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Product complaint # (b)(4).Date sent to fda: 12/6/2018.Additional information was requested and the following was obtained: do you have photos for the patient procedure date (b)(6) and patient procedure date (b)(6)? no other photos.Do you have event dates or details for any additional patient events? no further information.Please describe where the dermabond and prineo 60 were used on each patient? yes, both were used on patient, but on different sections of the patient.Where specifically was the prineo 60 used on the patient? used on higher tension area panniculectomy section where was the dnx12 used on the patient? used on smaller incisions, used for the breast portion.
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