MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for NEOVEIL NV-L-015G manufactured by Gunze Limited.
[125591842]
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
[125591843]
(b)(6) 2018: partial resection was performed on upper left lobe cancer (primary). As treatment for lung fistula, neoveil was applied to lung cancer resected area with 5 ml fibrin glue ("bolheal" km biologics co. Ltd. Lot number h 5717). Blood pressure decreased and facial flush occurred 10 to 15 minutes after application. There was no rash. Both the anesthesiologist and surgeon determined that anaphylactic shock was caused by either neoveil or bolheal. 0. 3 mg of adrenaline intramuscularly, 5 mg of polaramine intravenously, neoveil was removed and the surgical field was washed with physiological saline. The patient recovered the same day. (b)(6) 2018: the patient was discharged from the hospital. The patient has the following operation history, using neoveil and fibrin glue ("beriplast" csl behring) at that time. In (b)(6) 2017, right middle lobe lung cancer was resected. At that time, neoveil (nv-l-015g, lot number unknown) was pasted with 5 ml of beriplast (lot number unknown).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007958945-2018-00002 |
| MDR Report Key | 8022539 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-09-28 |
| Report Date | 2018-10-22 |
| Date Reported to FDA | 2018-10-22 |
| Date Reported to Mfgr | 2018-10-03 |
| Date Added to Maude | 2018-10-31 |
| 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 | 2018-10-31 |
| Model Number | NV-L-015G |
| Catalog Number | NV-L-015G |
| Lot Number | 18030401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| 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 | 2018-10-31 |