MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Catalog Number	PHSE1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2024
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.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.Additional information provided: bilateral inguinal hernia - hernia cure with phs plate symptomatic hib clinical recall during effort intervention: under general anesthesia.Supine dermal.Incision of the inguinal oblique cutaneous incision opening of the aponeurosis of the great oblique.Placing on lake of the spermatic cord skeletoning of the cord.There is a direct hernia.Opening of the fascia transversalis placing a plate of prolene phs (ethicon) fixed by mersuture points 2/0 and fixed at the bottom on the cooper, the superficial part of the plate is split for the passage of the cord closure of the aponeurosis from great oblique to vicryl 0.Subcutaneous plane to vicryl 2/0.Ethilon 3/0 on the skin.Same contralateral gesture.Current state of the patient: severe pain in the pubis and left groin since i had surgery for double inguinal hernias.They prevent me from running or walking on a daily basis.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.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the following information on the authorization to use or disclose information form attached: your surgeon¿s name, email, phone number, address.Your signature.Please scan the signed form and email back to ethicon.
Event or Problem Description
It was reported by a patient that they underwent a double inguinal hernia operation on (b)(6) 2024 and mesh was used.The patient experienced severe pain in the pubis and left groin continuously.Additional information was requested.
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: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24443968
• Report Number: 2210968-2026-01994
• Device Sequence Number: 10307797
• Product Code: FTL
• UDI-Device Identifier: 10705031048935
• UDI-Public: (01)10705031048935(17)280731(10)41893J01
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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 Catalogue Number: PHSE1
• Device Lot Number: 41893J01
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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: Other
• Patient Sex: Unknown