(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 any photos? name of procedure what is meant by permanent scarring? what date did the reaction occur post op? 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? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? 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? what is the most current patient status?.
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