(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.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.Additional information was requested and the following was obtained: what is the procedure name and initial procedure date? total knee arthroplasty.How was the prineo applied on the mesh? one layer and slight overlap on skin.What prep was used prior to product application? wipe down with saline and dried.What was the location and incision size of the application? l knee - around 18-20 cm in length.Was a dressing placed over the incision? if so, what type of cover dressing used? sterile gauze 4x4 and ace wrap.What date did the reaction occur on? in hospital two days post op.What does the reaction look like and how large of an area does the reaction cover? entire surface of patients skin under the polyester mesh.Do you have any pictures of the reaction? already submitted pictures.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Removed dressing - patient put on steroids to be safe.No infection was present, and no dehiscience occurred and skin irritation has subsided significantly.Can you identify the lot number of the product that was used? n/a.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? the patient was asked about any allergies pre surgery and did not have any known allergies.If the patient is female, please ask if they were exposed to similar products, such as artificial nails? n/a.What is the most current patient status? significant improvement and skin reaction rash has gone down.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) n/a.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? prineo has not been used on this patient prior to the tka.
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