MalfunctionOXC
NEOVEIL (SHEET)
Received Jan 26, 2026 · Event occurred Oct 28, 2025
Report 3012602431-2026-00011 · MDR key 24185994
Device
Generic name
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Manufacturer
Gunze LimitedModel number
NV-M-015GLot number
25032602
Product problems
- Contamination /Decontamination Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.