MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

Catalog Number	PMII
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fatigue (1849); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Depression (2361); Constipation (3274); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6)2017 and mesh was implanted.It was reported that the patient underwent removal surgery and repair of right inguinal hernia on (b)(6) 2022 during which the surgeon note recurrent inguinal hernia with extensive scar tissue, previous inguinal hernia mesh noted stuck to the vas deferens.It was reported that the patient underwent excision of right inguinal mesh on (b)(6) 2023 during which the surgeon noted scarring in the right inguinal region from previous hernia, mesh scarred into cord contents in the floor of the inguinal canal.It was reported that the patient experienced pain, constipation, unable to perform heavy lifting, hernia recurrence, discomfort, depression, limited mobility, adhesion, mesh migration, deformation, mesh shrinkage, excessive scarification, failure to incorporate and chronic inflammation.No additional information provided.
Additional Manufacturer Narrative
Date sent to the fda: 2/10/2025 h6: appropriate term / code not available (e2402) utilized to capture deformation, and mesh shrinkage.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4) submitted for adverse event which occurred on 10/10/2022.(b)(4) submitted for adverse event which occurred on 06/19/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, 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.

• 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21351337
• Report Number: 2210968-2025-01467
• Device Sequence Number: 15704050
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: (01)10705031049024(17)220630(10)LHH101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: 06/30/2022
• Device Catalogue Number: PMII
• Device Lot Number: LHH101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2017
• 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 Age: 66 YR
• Patient Sex: Male