(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.Email sent to sales rep through (b)(4) requesting the following information: do you have any photos? name of procedure 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? do you have the lot number involved ? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? 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? do you have any product of same lot available for evaluation?.
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It was reported that a patient underwent a plastic surgery procedure on an unknown date and topical skin adhesive was used.Post operatively, the patient returned with an allergic reaction wherever the topical skin adhesive tape was applied.The doctor removed the topical skin adhesive, applied topical steroids and discharged the patient.Additional information has been requested.
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Additional information was requested and the following was obtained: procedure date: (b)(6)2017 name of procedure ¿ breast reduction what date did the reaction occur post op? reaction about pod 4-5 what prep was used prior to, during or after prineo use? prep with chloroprep was a dressing placed over the incision? if so, what type of cover dressing used? no other dressing.Patient pre-existing medical conditions - no allergies to adhesives or formaldehyde.
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