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 Codes	Neuropathy (1983); Pain (1994)
Date of Event	03/01/2023
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: as the lot number for the device involved in the event was not provided, 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.Operative report: indication: patient with right inguinal hernia appearing clinically external oblique; history of right hernia repair in childhood.Field of ddb on agammaglobulinemia.Intervention: cure of direct right inguinal hernia with prosthetic network placement patient on ag.Inguinal incision.Ilio inguinal block with naropeine 20 cc 2%.Opening of the aponeurosis of the superior oblique muscle.Individualization and dissection of the cord.It is a direct hernia with voluminous fatty sacs and parietal fragility; the area is reworked by the history.Opening of the fascia transversalis very distended.Hemostasis.Placement of a preperitoneal prolène phsm network anchored to the cooper, the crural arch and the posterior face joint tendon by pds points 3/0.Closure of the aponeurosis of the superior oblique muscle.Subcutaneous vicryl 2/0, intradermal subject resorbable for skin vicryl 3/0 rapid.
Event or Problem Description
It was reported that a patient underwent an right inguinal hernia repair on an unknown date and mesh was implanted.The patient developed severe and disabling pain, diagnosis of neuropathic pain with no effect of usual painkillers treatment with gabapentin 600, 3 taken daily.No additional information was provided.

• 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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24283723
• Report Number: 2210968-2026-01397
• Device Sequence Number: 18206288
• 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
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: PHSM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/06/2026
• 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