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

Model Number	NV-M-015G
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Mfr report #: 3010668881-2025-00006.A needle-like foreign object was identified by the attending physician in a case involving the use of nv sheet.The needle-like foreign object was discovered when the attending physician examined the nv sheet that had been opened by a nurse and placed in a petri dish.The foreign object was removed from the nv sheet, and the sheet was used as intended.There was no health injuries to the patient and no surgical delays.

• 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: 24185994
• Report Number: 3012602431-2026-00011
• Device Sequence Number: 7976312
• Product Code: OXC
• UDI-Device Identifier: 04548366322528
• UDI-Public: 04548366322528
• 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): 01/26/2026
• Report Date (Section F): 01/26/2026

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 Model Number: NV-M-015G
• Device Lot Number: 25032602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/26/2026