MAUDE Adverse Event Report: Ethicon Inc. ULTRAPRO ADVANCED; Mesh, Surgical, Polymeric

Catalog Number	UPA31015
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a laparoscopic tension-free repair of inguinal hernia procedure on (b)(6) 2026, and suture was used.The nurse took out a patch and opened the aluminum foil bag to find a white linear foreign object on the patch.To be safe, a new patch was used instead.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/24/2026.Video analysis: this is an analysis for a video submitted to ethicon for evaluation.During the visual analysis, the following was observed: one video and one photo were submitted for analysis.The video or photo shows a mesh outside its packaging on a surface; a foreign substance is observed on the mesh.As the device was not returned, an analysis investigation could not be performed.Based on the video and photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.A manufacturing record evaluation was performed for the finished device upa31015.; xgbcpzd0 number, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Additional information was requested, and the following was obtained: is it possible that the foreign material fell into packaging upon opening of device? no.Was the product seal on the foil still intact when the package was opened? unknown.Will the device be returned for evaluation? if yes please return all relevant packaging material.Was the procedure completed without any adverse effect to the patient? yes.

• Brand Name: ULTRAPRO ADVANCED
• Common Device Name: Mesh, Surgical, Polymeric
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.-GmbH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50882226
• Report Number: 2210968-2026-09573
• Device Sequence Number: 9799550
• Product Code: FTL
• UDI-Device Identifier: 10705031236998
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial

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: UPA31015
• Device Lot Number: XGBCPZD0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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