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Product complaint # (b)(4).Additional information provided patient complaints observed by dr.(b)(6) during follow-ups after the use of dermabond prineo in tkr.Patients are coming with adverse skin reactions ranging from redness and rashes to vesicles, pustules, and in several cases, progression to chronic dermatitis.Many of these patients have required referral to a dermatologist for further management.As per dr.(b)(6) such reactions are now being observed at high frequency, which is significantly higher than expected.It is important to highlight that dr (b)(6) is aware of the published data indicating an approximate 1% incidence of adverse reactions and based on that understanding, he had not raised concerns earlier.However, given the current frequency and severity of cases being observed in his practice.Upon follow? up with the sales representative, it was identified that product code clr222 was also involved in the complaint.As the quantity of products involved was initially unknown, one (1) unit of each product (clr422 and clr222) was added to the complaint for documentation purposes.During further follow?up, the sales representative provided the following batch details; however, the exact quantity of each batch involved remains unknown: clr422: batch numbers: 10axhx, 107mkg clr222: batch numbers: 108akc, 109725 as informed by the sales representative, adverse effects were reportedly observed in multiple patients.However, the exact number of patients affected is unknown at this time.Similarly, the exact number of products involved could not be confirmed.Based on tentative information provided by the sales representative, it is estimated that approximately: 5 units of clr422, and 11 units of clr222.Additional information has been requested and received.Please describe the patient manifestations of the reported reaction (location, severity, appearance, generalized or local reaction).At the site of application (knee) if generalized reaction, please provide each location, severity and appearance.N/a what date /day post op was the reaction noted? approx.10 -15 days was any prescription strength medication prescribed? please specify? yes topical antibiotics was the topical steroid prescription strength? not sure were any other prescription medications prescribed? not sure was any surgical intervention performed? no were cultures and sensitivities performed? if yes, results? no please describe how the adhesive was applied.As per our product training how was the wound cleaned and dried prior to prineo/ dermabond application? 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 was used? no dressing applied over prineo has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? no is the patient hypersensitive to pressure sensitive adhesives? not sure was patient screening done prior the procedure, e.G.Check patient is not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no sure was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no does the patient have allergies to medication, food, etc.? no was an allergy test performed? if so, please provide results.No what was the tissue condition (normal, thin, calcified, fragile, diseased)? normal for the original intended closure, how were all layers closed? layer closure" additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.How was the wound cleaned and dried prior to prineo application? were any pre-op cleansing procedures changed recently? if yes, please describe when was the prineo product removed from the patient? what prep was used prior to, during or after adhesive use? patient demographics: initials / id, gender, age or date of birth; bmi current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis.Additional information: d4, h4 - the actual device lot number associated with this event is not known.Possible batch numbers are reported as follows: a manufacturing record evaluation was performed for the possible finished device lots, and no non-conformances were identified.Clr222 lot 109725 mfg date: 06/18/2025 exp.Date - 05/31/2027, lot 108akc mfg date: 05/10/2025 exp.Date - 04/30/2027.Clr422 lot 10axhx mfg.Date - 09/06/2025 exp.Date - 02/28/2027 , lot 107mkg mfg.Date - 04/05/2025 exp.Date - 09/30/2026.No product is available for return.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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