Product complaint # (b)(4).Additional information: did the patient experience a post-op device malfunction? no, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? patient was prescribe with topical steroid to manage the allergic reaction, patient status/ outcome / consequences? yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? allergic reaction was noticed pod 7 post-tkr from 2nd exposure to dermabond prineo, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe.Topical corticosteroid 0.05% was prescribed to patient.Patient skin has healed since without any underlying issues.Is the patient part of a clinical study? unknown.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.What was the procedure date? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions).Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? current patient status.No product is available for return.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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