| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NEOVEIL | STAPLE LINE REINFORCEMENT MATERIAL | GUNZE LIMITED | OXC | NV-L-015G | NV-L-015G | 18030401 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-22 | 0 | 1. L |
Patient 1
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 1
ON (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. ON (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).