It was reported a patient underwent a right total knee replacement surgery on (b)(6) 2022 and topical skin adhesive was used.Post op, he patient presented with an infection on (b)(6) 2022.Treatment was not provided.It was stated, incision and drainage was not needed.Doctor indicated that the patient is healing fine now.No further information was provided.Additional information has been requested.
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(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient's infection? no.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Local infection.What is the alleged deficiency of each of the sutures products and prineo? unknown.What tissue layer was each suture type reported used to close? stratafix symmetric on fascia, stratafix bidirectional on subcuticular, and dermabond prineo on skin.Does the surgeon believe the suture and/or prineo had a causal impact on the infection? yes.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? unknown.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? unknown.Were cultures performed? if so, please provide the results.Unknown.How much and what type of drainage is present in this wound? unknown.Was any prescription strength medication prescribed? please specify? unknown.Was any surgical intervention performed? no.Please describe how was the adhesive was applied.Unknown.What prep was used prior to, during or after adhesive use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? unknown.Patient demographics: initials / id, gender, age or date of birth; bmi? unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions)? unknown.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Product code and/or lot of product used? unknown.Current patient status.Healing okay.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unknown.No product is available for return.Note: events reported on mw# 2210968-2022-06708, mw# 2210968-2022-06709.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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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