Product complaint # (b)(4).Attempts to obtain the following information has been performed but not received.If the further details are received at a later date a supplemental medwatch will be sent please describe how was the adhesive was applied.What prep was used prior to, during or after prineo 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? were any patch or sensitivity tests performed? patient demographics: initials / id; age or date of birth; bmi ; patient pre-existing medical conditions (ie.Allergies, history of reactions) does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).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.
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It was reported a patient underwent a right total knee arthroscopy procedure on (b)(6) 2019 and topical skin adhesive was used.The patient was discharged and during the follow-up visit on (b)(6) 2020, when the adhesive was removed, the doctor noticed skin reaction, under adhesive and all around knee-pruritic papules/erythematous.Patient placed on prednisone 40mgx4 days, followed by antibiotics.Patient status, doing well.No product will be returned.Additional information was requested.
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