Product complaint # (b)(4) the following information has been requested and was received.¿ primary procedure date: unknown ¿ procedure e.G.Tkr?: tkr (total knee replacement) ¿ surgeon: dr jonathon young ¿ if the reaction is on the knee, was the product applied while knee was extended or flexed? unknown ¿ how long did the reaction occur post primary op? 1 week ¿ describe the reaction (e.G.Blister/red/infected/mild reaction/severe reaction/itch): all of the listed examples with various degrees of intensity ¿ did the patient have to be readmitted for treatment? no ¿ were any iv steroid/topical steroid/oral steroid/other treatments used to manage the reaction? topical steroids ¿ what is the most current patient status? all symptoms are reducing.¿ who applies the product (surgeon/assistant/nurse)? surgeon.¿ what prep was used prior to, during or after prineo use? betadine (povidone-iodine), or chlorhexidine? unknown ¿ was a protective, dry wound dressing such as gauze applied and was it applied only after the liquid topical skin adhesive has completely polymerized and the dermabond¿ prineo¿ is no longer tacky to the touch? unknown ¿ type of dressing use on top of prineo (e.G.Honeycomb/opsite/gauze/crepe) unknown ¿ was the application site cleansed thoroughly with saline or isopropyl alcohol to remove any remaining blood, fluids, or topical medications/anaesthetics, including skin preps, and then patted dry? unknown ¿ was a thin layer applied as per ifu? unknown however surgeon has been using for a long time ¿ patient hypersensitivity to cyanoacrylate, formaldehyde, or pressure sensitive adhesive and using relatable terms such as hypersensitive to bandages, tape, hobbyist glue, cosmetic eyelashes or artificial nails or any recent exposure? unknown.¿ were any patch or sensitivity tests performed prior to the procedure? unknown ¿ patient¿s demographics: initials / id; age or date of birth; bmi; gender ¿ unknown ¿ patient pre-existing medical conditions (e.G.Allergies, history of reactions): unknown ¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes ¿ did the applier change a fresh pair of glove prior prineo application? unknown ¿ any images available? no -were the topical steroids prescribed by a physician or purchased over the counter? it was prescribed.The following information has been requested however not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.¿ can you identify the lot number of the product that was used? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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It was reported a patient underwent a total knee replecement on an unknown date in 2020 and topical skin adhesive was used.About one week after surgery, patient had mild to moderate irritation with inflammation, itching and small blistering.Treated with prescription of topical steroids.Symptoms reducing.Additional information has been requested.
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