MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH 10X15V; MESH, SURGICAL, POLYMERIC

Catalog Number	PHY1015V
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Seroma (2069); Hernia (2240); Swelling/ Edema (4577)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an umbilical hernia repair procedure on (b)(6) 2014 and mesh was implanted for parietal reinforcement type.Following this operation, the patient began to have pain and was consulted again.The patient underwent a second operation on (b)(6) 2016.During this one, the surgeon discovered that part of the first parietal reinforcement had detached and a new hernia at the level of the white line.The patient was implanted with a second reinforcement (not a j&j device) during this second operation.Current state of the patient: after the first operation, the patient felt abdominal pain that they thought was due to the formation of the new hernia and the fact that the prosthesis had come off.But it really followed the second operation that the patient started to have abdominal pain, then at the hip, then at the back.The patient suffers from chronic and disabling pain in daily life.The different treatments put in place for these pains are without great results, the pains are daily.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.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 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.H6 component code: g07002 ¿ device not returned.

• Brand Name: ETHICON PHYSIOMESH 10X15V
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22395086
• Report Number: 2210968-2025-07836
• Device Sequence Number: 18431973
• Product Code: FTL
• UDI-Device Identifier: 10705031132306
• UDI-Public: 10705031132306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: PHY1015V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 07/03/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown