MAUDE Adverse Event Report: GUNZE LIMITED NEOVEIL SHEET; Mesh, surgical, absorbable, staple line reinforcement

Model Number	NV-L-015G
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr report #: 3010668881-2025-00002.A chest ct scan was performed several days postoperatively for follow-up in a patient treated with nv and bolheal.The scan revealed extensive adhesions throughout the pleural cavity.The attending physician inquired with the sales representative about why extensive adhesions had developed despite targeting localized inflammatory response at specific application sites.In response to the sales representative's answer, the physician provided additional information that the possibility of anaphylactic shock due to fibrin glue had been overlooked.The patient experienced significant hypotension and mild shock symptoms postoperatively, which were stabilized with norepinephrine administration.The drain was subsequently removed.No pleural effusion was observed, and the clinical course has been favorable.Management of ascites is planned going forward.

• 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
• MDR Report Key: 23275793
• Report Number: 3012602431-2025-00090
• Device Sequence Number: 4916356
• Product Code: OXC
• UDI-Device Identifier: 04548366322481
• UDI-Public: 04548366322481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2025
• Report Date (Section F): 10/12/2025

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-L-015G
• Device Lot Number: 25050801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/12/2025