MAUDE Adverse Event Report: Ethicon Inc. DERMABOND PRINEO; Surgical Sealant

Catalog Number	CLR602US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Local Reaction (2035); Blister (4537); Swelling/ Edema (4577)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Title: formaldehyde emissions from 2-octyl cyanoacrylate: quantified risk for allergic contact dermatitis.The aim of this study is to quantify the amount of formaldehyde emitted from 2-octyl cyanoacrylate (oca) adhesives and to assess the risk that these formaldehyde emissions could contribute to allergic contact dermatitis (acd) in exposed patients.Dermabond prineo (eth) was used for skin closure of surgical incisions after surgery.Reported complications: demabond prineo (eth) allergic contact dermatitis (acd) (n=?) treatment: not reported erythema (n=?) treatment: not reported edema (n=?) treatment: not reported vesicles/blister formation (n=?) treatment: not reported systemic erythema (n=?) treatment: not reported increased risk of surgical site infection (ssi) secondary to hypersensitivity reactions (n=?) treatment: not reported in conclusion, 2-octyl-cyanoacrylate-mesh-systems emit formaldehyde at levels exceeding sensitization and inhalation thresholds, raising concern for dermal and respiratory exposure, particularly in sensitised individuals.Prior sensitisation from adhesives such as nail, eyelash or super glues may heighten risk.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: contact dermatitis.2026 jun;94(6):635-644.Https://doi.Org/10.1111/cod.70110 epub 2026 feb 16.Pmid: 41698688; pmcid: pmc13139693.

• Brand Name: DERMABOND PRINEO
• Common Device Name: Surgical Sealant
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50717466
• Report Number: 2210968-2026-09087
• Device Sequence Number: 10586537
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• UDI-Public: 10705031024168
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K152490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CLR602US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown