(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.Please explain what is happening under the mesh.Please explain changing of mesh color? bleeding? please describe how was the adhesive applied on the tape.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? was the site cultured? if so, what bacteria were identified? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? do you have the product code and lot number involved.What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions) for female patients ask: was the patient exposed to similar products, such as artificial nails.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.
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It was reported that a (b)(6)-year-old female patient underwent an elective left total hip replacement on (b)(6) 2018 and topical skin adhesive was used.The patient noticed itching along the incision on (b)(6) 2018 and saw surgeon on (b)(6) 2018.The patient was prescribed benadryl and benadryl cream.The surgeon noted an erythematous rash around the topical skin adhesive.The patient was seen again on (b)(6) 2018 and was started on zantac, zyrtec, benadryl, triamcinolone cream, and keflex.Additional information was requested.
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