MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for SEALANT,POLYMERIZING manufactured by Baxter Healthcare Corporation.
[183373734]
Literature article: akar, e. , arif haberal, m. , & dikis, o. ? Efficacy of surgical tissue glues and supporters for treatment of prolonged air leaks in bullous emphysema?. J coll physicians surg pak 2020; 30(1):57-61. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183373735]
It was reported that a patient with radiologically confirmed bullous emphysema, underwent video assisted thoracic surgery for secondary spontaneous pneumothorax in which conseal was used. It was reported the patient underwent a wedge resection with conseal, used at the suture line and a non-baxter stapler supported by peri-strips. It was reported post-operatively, the patient experienced a prolonged air leak. The cause of the air leak was not reported. Treatment for the event was not reported. At the time of this report, the patient outcome was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-00919 |
| MDR Report Key | 9746222 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-02-24 |
| 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 | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Street | 2024 W WINTON AVE |
| Manufacturer City | HAYWARD CA 94545 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | SEALANT,POLYMERIZING |
| Product Code | NBE |
| Date Received | 2020-02-24 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |