MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Catalog Number	PHSM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/13/2022
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 it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent inguinal hernia repair on (b)(6) 2022 and mesh was implanted.Following surgery, the patient reported experiencing severe residual pain after this repair of the left inguinal hernia.The pain prevented the patient from sitting for more than 30 minutes, caused nighttime pain, back pain, and an inability to play sports.The patient further reported pubalgia, pain of the pubic symphysis, ilio-inguinal pain, and sciatica were the terms most often used by doctors to describe their symptoms.The patient had to undergo several pelvic mris and ultrasounds, which did not reveal any abnormalities.The patient attended sessions of physiotherapy, osteopathy, and chinese medicine, had two infiltrations (injections), and ultimately went to a pain evaluation and treatment center (cedt) to receive transcutaneous electrical nerve stimulation (tens) treatment for six months.This last treatment succeeded in making the pain tolerable and manageable.No further information is available or could be obtained as reporter details have not been disclosed (confidential).
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.Corrected information: d4.Lot number.D4: udi: as the lot number for the device involved in the event was not provided/valid, the full udi is currently not available.

• Brand Name: PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24120638
• Report Number: 2210968-2026-00743
• Device Sequence Number: 13104271
• Product Code: FTL
• UDI-Device Identifier: 10705031048997
• UDI-Public: 10705031048997
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: PHSM
• Device Lot Number: 3675J01
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown