MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number	CLR422
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported upon opening on 4-mar-2026 the topical skin adhesive had an issue.Opened box and observed that unit was leaking through the packaging.One of the packets appear to be growing something inside the glue tube.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: patient status/ outcome / consequences --> no patient involvement, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown.Details of complaint: box of dermabond prineo appear to have been leaking.A box of dermabond prineo was opened to discover the products inside the box had been leaking through the packaging.One of the packets appear to be growing something inside the glue tube.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.- where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) - please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? - are there any photos of the foreign matter available? - is it possible that the foreign material fell into packaging upon opening of device? - was the product seal on the foil still intact when the package was opened? - will the device be returned for evaluation? if yes please return all relevant packaging material.Furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.- was the procedure completed without any adverse effect to the patient? - please provide the source or name of person providing answers to follow-up questions: a manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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 42CM MSH 3.8ML ADHESIVE
• Common Device Name: CUTANEOUS TISSUE ADHESIVE WITH MESH
• 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: 25427761
• Report Number: 2210968-2026-06096
• Device Sequence Number: 10335921
• Product Code: OMD
• UDI-Device Identifier: 10705031240421
• UDI-Public: (01)10705031240421(17)270531(10)10CM69
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CLR422
• Device Lot Number: 10CM69
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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
• Patient Sex: Unknown