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 Code	Unspecified Infection (1930)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: comparative study of 2-octylcyanoacrylate plus polymer mesh tape and surgical stapler for preventing surgical site infection following corrective fusion in patients with adult spinal deformity: a retrospective cohort study.The aimed of this study is to investigate the efficacy of using a 2-octylcyanoacrylate adhesive with a self-adhesive polymer mesh tape (2opmt) for preventing ssi after long-segment corrective fusion in adult spinal deformity (asd) patients between 2010 and 2021, with minimum 1-year follow-up.From 2010 to 2015, wounds were closed with subcuticular sutures plus skin staples (stapler group, n = 267).From 2015 onward, wounds were closed with subcuticular continuous sutures plus the 2opmt system (2opmt group, n = 221).Dermabond primeo (eth) was used for novel skin closure system with combined a polymer mesh tape with a topical cyanoacrylate glue.Reported complications: 2opmt (n=221) dermabond primeo (eth).Superficial surgical site infection (ssi) (n=3) treatment: managed successfully with debridement and targeted antibiotics.Deep surgical site infection (ssi) (n=3) treatment: managed successfully with debridement and targeted antibiotics.Infection (n=?) treatment: reoperation.In conclusions, wound closure using 2-octylcyanoacrylate plus poly mer mesh tape (2opmt) in corrective fusion surgery for adult spinal deformity was associated with a lower inci dence of postoperative wound infections than wound closure with conventional skin staples.Even after adjust ing for patient and surgical factors through propensity score matching¿including asa classification and other potential confounders¿the 2opmt group demonstrated a significantly reduced ssi rate relative to the stapler group (overall or 0.32, 95% ci 0.10¿0.99; p = 0.043).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information has been requested however not received.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? no product is available for return.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: j orthop surg res.2025 dec 5;21(1):28.Doi: 10.1186/s13018-025-06508-2.Pmid: 41351053; pmcid: pmc12797984.Journal article attached.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.

• 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24888375
• Report Number: 2210968-2026-04009
• Device Sequence Number: 21415163
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• UDI-Public: 10705031024168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/15/2026
• 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: Required Intervention
• Patient Sex: Unknown