Product complaint # (b)(4).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent date of procedure? on (b)(6) 2021.On what date did the reaction occur? on (b)(6) 2021.Did the patient have to be readmitted for treatment? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Canesten and prescribed a hydrocortisone 1% cream.If medication was required, was it prescribed or purchased over-the-counter.What is the most current patient status? recovered.Can you identify the lot number of the product that was used? no.Was prineo or dermabond or any skin adhesive used on the patient in a previous surgery or wound closure? no.Who applies the product (surgeon/assistant/nurse)? surgeon.What prep was used prior to, during or after prineo use? betadine (povidone-iodine), or chlorhexidine? chlorhexidine.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? yes.Type of dressing use on top of prineo (e.G.Honeycomb/opsite/gauze/crepe): honeycomb.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? yes.Was a thin layer applied as per ifu? yes.Patient hypersensitivity to cyanoacrylate, formaldehyde, or pressure sensitive adhesive and using relatable terms such as hypersensitive to bandages, tape, hobby glue, cosmetic eyelashes or artificial nails or any recent exposure? no.Were any patch or sensitivity tests performed prior to the procedure? no.Patient¿s demographics: initials, age or date of birth; bmi; gender ¿ female, (b)(6), bmi 26.Patient pre-existing medical conditions (e.G.Allergies, history of reactions): did the applier change a fresh pair of glove prior prineo application? yes.The images provided, are they from patients where the prineo was removed at approx.4-5 weeks or at the 2 weeks mark? 4 weeks.Who removes the prineo? hcp or patients? patient.And have since now decided to advice them to remove them at 2 weeks in the hope of avoiding these reactions.No product is available for return.Note: events reported on mw#: 2210968-2021-08106, 2210968-2021-08107, and 2210968-2021-08108.
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