MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for FLOSEAL 1505291 manufactured by Baxter Healthcare Corporation.
[101996612]
Patient Sequence No: 1, Text Type: N, H10
[101996613]
Ampoule would not fill into thrombin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7327045 |
| MDR Report Key | 7327045 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-02-16 |
| Date of Event | 2017-10-30 |
| Report Date | 2018-02-16 |
| Date Reported to FDA | 2018-02-16 |
| Date Reported to Mfgr | 2018-02-16 |
| Date Added to Maude | 2018-03-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | FLOSEAL |
| Generic Name | ABSORBABLE COLLAGEN HEMOSTATIC AGENT WITH THROMBIN |
| Product Code | PMX |
| Date Received | 2018-03-09 |
| Model Number | 1505291 |
| Catalog Number | 1505291 |
| Lot Number | VNFAR107 |
| Device Expiration Date | 2019-10-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-09 |