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

Model Number	NV-L-05G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A rash developed on the skin where the nv was inserted, matching the shape of the nv.During the rash, there was pain and a feeling of tightness.Approximately two weeks post-surgery, the skin where the nv was inserted became red in the shape of the nv.There was no fever, and blood tests showed no abnormalities.The attending physician stated it was not an infection.After administering antibiotics for several days, the redness subsided, so follow-up was continued as an outpatient.Subsequently, a second episode of redness occurred in the same area.Tests were performed, but no abnormalities were found.The type of antibiotic was changed, and outpatient treatment continues.As of the outpatient visit on (b)(6) (wed), the redness had subsided significantly, with only one small area remaining red.The plan is to continue observation.

• 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: 23880368
• Report Number: 3010668881-2025-00004
• Device Sequence Number: 21238180
• Product Code: OXC
• UDI-Device Identifier: 04548366322450
• UDI-Public: 04548366322450
• 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-L-05G
• Device Lot Number: 24042302
• 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: 06/09/2025
• 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