MAUDE Adverse Event Report: ETHICON INC. VCL MESH KNIT UD 6INX6IN; MESH, SURGICAL, POLYMERIC

Catalog Number	VKMM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Hernia (2240); Ambulation or Postural Difficulties (2544)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an iliac crest free flap surgery-right side on (b)(6) 2018 and mesh was used.The surgery was due to cancer in the mandible and a craft from the hip was needed to replace the mandible.Explanted due to infection.Needed 2nd surgery to remove mesh and drain infection.There was puss and mrsa was identified.Prolonged hospital stay for weeks and possible incisional hernia that has not been followed up.Severe pain, difficulties walking, unstable gait.Pain is getting worse and no follow-up with possible incisional hernia occurred.The patient is very stressed about the deterioration of mobility and increased pain.No additional information could be requested due to confidentiality.
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.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
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.Additional information received: 1.Where was the infection? in the mandible or at the graft source area, the hip? the infection was in the pelvic area/hip.There was no mesh used in the mandible.2.Was the pain the patient was experiencing from the infection? my pain now is related to the infection i had while in hospital.3.Where was the mesh used? the mesh was used to hold muscle, bowel etc together.The hop graft required a huge incision from the hip to the pelvis.The hip graft removed was about 8 cm.4.What was explanted? the mesh or the graft? the mesh was totally removed because according to the surgical and clinical records it was full of puss.Assuming it was the source of the infection.

• Brand Name: VCL MESH KNIT UD 6INX6IN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22197192
• Report Number: 2210968-2025-06734
• Device Sequence Number: 18576713
• Product Code: FTL
• UDI-Device Identifier: 10705031056923
• UDI-Public: (01)10705031056923(17)270731(10)SJ2ASL
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K810428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: VKMM
• Device Lot Number: SJ2ASL
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2022
• 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; Hospitalization
• Patient Sex: Unknown