MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for NEOVEIL NV-L-015G manufactured by Gunze Limited.
[113264333]
Name of the adverse event: anaphylactic shock. Resected right middle lobe of lung to lung cancer in right middle lobe. Applied neoveil and fibrin glue("bolheal" kaketsuken) to pulmonary fistula part to deal with pulmonary fistula. After that, rash appeared on neck, trunk and limbs. Additionally, the blood pressure decreased rapidly. Above symptoms are observed during the chest closure, so opened the chest promptly, removed neoveil and fibrin glue as much as possible, and the thoracic cavity was washed. After that, chest closure was performed. The patient pulled out the drain on 9th postoperative day and was discharged 2 weeks after the operation. The doctor judged that the anaphylactic reaction was recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007958945-2018-00001 |
| MDR Report Key | 7664577 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-05-09 |
| Date Facility Aware | 2018-06-04 |
| Report Date | 2018-06-21 |
| Date Reported to FDA | 2018-06-21 |
| Date Reported to Mfgr | 2018-06-04 |
| Date Added to Maude | 2018-07-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOVEIL |
| Generic Name | STAPLE LINE REINFORCEMENT MATERIAL |
| Product Code | OXC |
| Date Received | 2018-07-05 |
| Model Number | NV-L-015G |
| Catalog Number | NV-L-015G |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUNZE LIMITED |
| Manufacturer Address | 46 NATSUMEGAICHI, AONO AYABE, KYOTO 623-8513 JA 623-8513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5 | 1. Life Threatening | 2018-07-05 |