MAUDE Adverse Event Report: GUNZE LIMITED NEOVEIL(SHEET); MESH, SURGICAL, ABSORBABLE, STAPLE LINE REINFORCEMENT

Model Number	NV-M-015G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Type of Reportable Event	Serious Injury
Event or Problem Description
The product was used in a case at (b)(6) hospital.The first case involved a right upper lobectomy in 2019, where the product was divided into 8-12 pieces and placed in the right middle lobe following the right upper lobectomy.Two years after the first case, fungal infection was observed, and re-thoracotomy was performed in 2021.(surgical intervention was performed as oral medication did not result in improvement.) during the re-thoracotomy, it was confirmed that the product remained in the body.The retained condition was almost the same as at the time of placement, and it was immediately identifiable as the product.A 2-3 mm membrane had formed around the product, and fungus was confirmed throughout the lung, raising concerns that the product may have become a source of infection and fungal growth.The product was removed as much as possible, and there were no issues with the patient's prognosis.2019: used in surgery 2021: thoracotomy performed due to fungal infection, two years after the first use 2025: on (b)(6), during a presentation at the facility, dr.(b)(6) information about this case and raised questions.

• Brand Name: NEOVEIL(SHEET)
• Common Device Name: MESH, SURGICAL, ABSORBABLE, STAPLE LINE REINFORCEMENT
• Manufacturer (Section D): GUNZE LIMITED; 46 natsumegaichi, aono; ayabe, kyoto 623-8 513; JA 623-8513
• Manufacturer (Section G): GUNZE LIMITED; 46, natsumegaichi, aono; ayabe, kyoto 623-8 513; JA 623-8513
• Manufacturer Contact: hidetoshi arimura ; jrwd dojima tower 5f, 2-4-27; dojima, kita-ku, osaka 530-0-003 ; JA 530-0003
• MDR Report Key: 23881192
• Report Number: 3010668881-2025-00005
• Device Sequence Number: 4771826
• Product Code: OXC
• UDI-Device Identifier: 04548366322528
• UDI-Public: 04548366322528
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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 Model Number: NV-M-015G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 12/23/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown