(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.(b)(4).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.How was the device applied to the incision? what layer of tissue and how many layers applied? what prep was used prior to product application? what was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? do you have any pictures of the reaction? please clarify if the cortisone cream was an otc product or prescription medication.Can the product code and lot number of the product be identified? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? for female patients, were they exposed to similar products, such as artificial nails? 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).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
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