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

Model Number	NV-M-015G
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
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
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
• 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: 23881810
• Report Number: 3010668881-2025-00006
• Device Sequence Number: 9622543
• 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?: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• 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
• Patient Sex: Unknown