MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED; ADHESIVE, TOPICAL SKIN

Catalog Number	DNX12
Medical Device Problem Codes	Break (1069); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.What quality issue was experienced with the product? the ampule was broken while still in the packaging.There was dermabond glue in the in the packaging as well as a crusty yellow/brown material.Please provide the status of the device(s) as it has not been received for analysis.H3 evaluation: visual analysis of the returned sample determined that the device was received in an unopened package.However, black foreign material was observed within the packaging.The material appeared to be a plastic component that does not belong to the returned device.Upon inspection, the unit was found to contain a polymerized vial, and the ampule was observed to be broken.These findings indicate that the pen device was compromised.No conclusion could be reached as to what may have caused the black foreign matter.Due to the damages found on the device, the complaint is observed, a possible cause for these conditions is due to improper handling during transit or storage.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.
Event or Problem Description
It was reported upon opening product on 4-may-2026 an issue was observed with topical skin adhesive.The product was visibly defective without opening the package.The product was never opened and was not used in surgery.Observed the defect while the product was on the shelf.Glue in the in the packaging as well as a crusty yellow/brown material.The device will be returned.Additional information has been requested.

• Brand Name: DERMABOND ADVANCED
• Common Device Name: ADHESIVE, TOPICAL SKIN
• 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: 25334214
• Report Number: 2210968-2026-05937
• Device Sequence Number: 9629629
• Product Code: MPN
• UDI-Device Identifier: 10705031203532
• UDI-Public: (01)10705031203532(17)271231(10)10CX2C
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: DNX12
• Device Lot Number: 10CX2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• 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