(b)(4).The following information has been requested however not received.If the further details are received at a later date a supplemental medwatch will be sent.Is a photo available of the reaction? were there any medical or surgical interventions performed? please describe how 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, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo skin adhesive used on the patient in a previous surgery or wound closure? what is the current status of the patient? 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 an decompression of a perineal nerve procedure on (b)(6) 2021 and topical skin adhesive was used.Seventy two hours post op, the patient developed a reaction consisting of redness, irritation, and blisters.The patient was treated with antibiotics and antihistamines.Additional information has been requested.
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