NEOVEIL(SHEET)
Received Dec 23, 2025 · Event occurred May 27, 2025
Report 3010668881-2025-00004 · MDR key 23880368
Device
Generic name
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Manufacturer
Gunze LimitedModel number
NV-L-05GLot number
24042302
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Rash
- Rash
Narrative
Description of Event or Problem
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.