(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 provide photos, initial procedure date, what date did the reaction occur post op? was the site cultured? if so, what bacteria were identified? what medical or surgical intervention was performed (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify was there any wound dehiscence? please provide doctors opinion on the reason that the prineo started to lift off and how many days post op did the event occur? was the prineo removed prematurely or reapplied? if yes, please.What prep was used prior to, during or after prineo use? 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? 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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