MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN; 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	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An enforcement action against a pharmacy shop involved in counterfeit prolene mesh.There was no patient involvement.
Additional Manufacturer Narrative
Product complaint (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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: ¿ how was the product purchased? ¿ the product wasn¿t purchased.The action happened on the basis of intel gathered during market scanning.¿ is there an indication of how the product was distributed? through local trader who use to get generic prolene from india and put the fake j&j label on it.¿ is there any indication of the source? we¿re working to track the upstream network.Given the current situation in bangladesh, the investigation is on hold.¿ based on the packaging, is there any indication of which market the original genuine product may have come from? india ¿ was the device used on a patient? if so, was there any patient consequence? we do not have that information.Photo analysis summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show a retail location, with packages labeled as pmii of product displayed on a surface.The image was visually inspected product code pmii and lot v3010.Upon visual inspection, multiple labeling discrepancies were identified, for example the writing style and font of the product illustration did not match the information on file.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.D4: udi: code pmii and lot v3010 mentioned in impacted product is not manufactured complaint is for counterfeit product.

• Brand Name: PROLENE MESH 3INX6IN
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21059756
• Report Number: 2210968-2025-00017
• Device Sequence Number: 12749564
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: 10705031049024
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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: V3010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2024
• Initial Report FDA Received Date: 01/02/2025
• 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
• Patient Sex: Unknown