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

Catalog Number	PMII
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the analysis of the returned product that confirmed counterfeit was observed.It was reported that a test sample procured during market survey suspected to be counterfeit.There were no reported patient or user harm.There were no significant delays reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/25/2026.H6 component code: c22 - photo analysis.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: how was the product purchased? is there an indication of how the product was distributed? is there any indication of the source? based on the packaging, is there any indication of which market the original genuine product may have come from? please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Photo analysis: this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show a sales unit package with product name prolene mesh 3inx6in product code pmii, lot #v4003 expiration date 06/2029.As the device was not returned, an analysis investigation could not be performed.The package has multiple discrepancies in the information that do not match the original packaging for ethicon sutures.Based on comparison of the provided image and packaging drawing in internal systems, this is a counterfeit observation on the packaging due to the position of the thumb notch on the pouch.In the provided image, the thumb notch is shifted significantly off-center instead of being aligned with the center of the seal area.The tolerance for the positioning of the thumb notch is 1/16¿.This shift in the positioning of the thumb notch is greater than that tolerance, meaning the pouch would not have been released from the manufacturer for use.Based on the samples received, the product is confirmed to be counterfeit due to the discrepancies found in the labeling and packaging material.As part of post-market surveillance, additional monitoring of claims information will be conducted to detect potential safety signals.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.

• Brand Name: PROLENE
• Common Device Name: Mesh, Surgical, Polymeric
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.-Aurangabad India; b-15/1, midc area; waluj; aurangabad ; IN
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50434368
• Report Number: 2210968-2026-08641
• Device Sequence Number: 10475716
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: (01)10705031049024(17)290630(10)V4003
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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: PMII
• Device Lot Number: V4003
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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