Product complaint # : (b)(4).The following information has been requested, and obtained.To date, the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.What is the procedure date? (b)(6) 2020.What date did the reaction occur on? a week later.What does the reaction look like and how large of an area does the reaction cover? red, covers entire mesh.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Yes, removed product, prescribed oral antihistamine, steroid cream to place on skin not on the incision, placed steri strips to cover wound.What is the most current patient status? stable.Can you identify the lot number of the product that was used? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery, or wound closure? yes (female had previous knee surgery).Please describe how was the adhesive was applied.Per ifu guidelines, 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? no dressing, just an ace bandage wrap for compression.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? yes placed product on wrist prior to surgery to see if there was a reaction patient demographics: initials / id, age or date of birth; bmi unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown.Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.
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It was reported a patient underwent a total knee on (b)(6) 2020, and topical skin adhesive with mesh was used.Post-operatively the patient had contact dermatitis.The area around the mesh was red and itchy.This was noted during a visit with the physicians assistant, two weeks after the procedure.The adhesive was removed, prescribed oral antihistamine, steroid cream to place on skin not on the incision, placed steri strips to cover wound.The patient had a previous knee procedure, and the surgeon had used this same product on her, and she did not have a reaction.Additional information has been requested.
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