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

Catalog Number	PMII
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/11/2026 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, 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.Additional information was requested, the following was obtained: did the reported issue contribute to any patient adverse consequences? - no.Please find the attached copy of courier slip.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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent a inguinal hernia repair procedure on (b)(6) 2026 and mesh was used.At the time of surgery surgeon open mesh its behave like soft mesh.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/1/2026 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, 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.H6 component code: g07002 no device problem found additional information: h3, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One empty overwrap packet was received for analysis.Product code pmii.The visual assessment of the returned sample.The mesh was not returned for analysis.As per this condition, the event described could not be confirmed.If additional information is made available, the investigation will be updated as applicable.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PROLENE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-AURANGABAD INDIA; b-15/1, midc area; waluj; aurangabad ; IN
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25142031
• Report Number: 2210968-2026-05097
• Device Sequence Number: 9325640
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: (01)10705031049024(17)290531(10)V4002
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PMII
• Device Lot Number: V4002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 06/16/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/02/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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
• Patient Sex: Unknown