(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Additional information was requested and the following was obtained: what are the procedure name(s) and date(s)? total knee replacement.What does the reaction look like and how large of an area does the reaction cover? redness and blistering only under the prineo tape.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Product removed and precautionary antibiotics prescribed.What is the most current patient status? unknown at this time.Are photos available of the reaction? no photos available.Initial procedure date: no, not available.What post op date did the reaction occur? reaction occurred prior to the 2 week follow up.Please describe how was the adhesive was applied on the tape: as per ifu; sales rep has reviewed technique with pa.What prep was used prior to, during or after prineo use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no known allergies.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? unknown.Do you have the lot number involved ? unknown.What is the physicians opinion of the contributing factors to the reaction? unknown.What is the most current patient status? unknown.Patient demographics: initials / id; age or date of birth; bmi ; gender - unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.
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