MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	PHSM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Pain (1994); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	11/12/2008
Type of Reportable Event	Serious Injury
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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.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: 1.If in your possession, may we have a copy of your operative report? 2.Does ethicon have your permission to contact your surgeon, if we would like to request more clinical information to be used for a product quality complaint investigation? 3.If so, please provide your surgeon¿s name and contact information and fill out the attached consent form? (email address, phone number, address).
Event or Problem Description
It was reported that a patient underwent an inguinal hernia repair procedure on (b)(6) 2008 and mesh was implanted.The patient reported they had: chronically sharp pain in the right groin.Obstruction of the right seminal fluid, inflammation of the prostate, epididymis and testicle of the right and right seminal vesicles.Chronic pain of the right testis.Reoperation made on (b)(6) 2015.Rely on removing a piece of surgical mesh with solid infiltration from this seminal fluid.Multiple steroid locks, right groin injection lignocaine.Treated in the clinic of pain treatment with a permanent effect.The need for multiple rehabilitation treatments carried out in stations and sanatoriums.Additional information was requested.

• Brand Name: PROLENE HERNIA SYSTEM MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25477127
• Report Number: 2210968-2026-06234
• Device Sequence Number: 15744421
• Product Code: FTL
• UDI-Device Identifier: 10705031048997
• UDI-Public: (01)10705031048997(17)130131(10)19117-01
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: PHSM
• Device Lot Number: 19117-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 07/02/2026; 08/12/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/29/2026; 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown