MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-21 for NEOVEIL NV-L-015G manufactured by Gunze Limited.
[111892050]
Judging from the situation of treatment, the cause of anaphylaxis is considered to be either neoveil or fibrin glue. Since fibrin glue contains heterologous proteins and warnings related to anaphylaxis is described in ifu of fibrin glue, we believe that it is highly possible that fibrin glue is the cause. However, the test to identify the allergen was not carried out, so it was not possible to prove that neoveil was not the cause.
Patient Sequence No: 1, Text Type: N, H10
[111892051]
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 | 3010668881-2018-00001 |
| MDR Report Key | 7625357 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-06-04 |
| Date Added to Maude | 2018-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 46 NATSUMEGAICHI, AONO |
| Manufacturer City | AYABE, KYOTO 623-8513 |
| Manufacturer Country | JA |
| Manufacturer Postal | 623-8513 |
| Manufacturer G1 | GUNZE LIMITED |
| Manufacturer Street | 46 NATSUMEGAICHI, AONO |
| Manufacturer City | AYABE, KYOTO 623-8513 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 623-8513 |
| 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 | 2018-06-21 |
| Model Number | NV-L-015G |
| Catalog Number | NV-L-015G |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 0 | 1. Life Threatening | 2018-06-21 |