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 2020-03-09 for COSEAL manufactured by Baxter Healthcare Corporation.
[182589021]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[182589022]
It was reported a patient underwent an unreported surgery in which conseal was used. It was reported approximately 27 days post operatively; the patient experienced a cerebral hemorrhage. It was reported the event developed due to patient treatment with a left ventricular assisting device. It was not reported if the patient was hospitalized for the event. Treatment for the event was not reported. At the time of this report, the patient was not recovered from the event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01279 |
| MDR Report Key | 9806284 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-03-09 |
| 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 | COSEAL |
| Generic Name | SEALANT,POLYMERIZING |
| Product Code | NBE |
| Date Received | 2020-03-09 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-09 |