MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 1998-09-03 for BAXTER LIFESPAN EPTFE VASCULAR GRAFT UNK NA manufactured by Baxter Healthcare Corp..
[110763]
This event was reported as poor venous outflow. No further information was provided
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-1998-00254 |
| MDR Report Key | 185647 |
| Report Source | 02 |
| Date Received | 1998-09-03 |
| Date of Report | 1998-08-04 |
| Date of Event | 1998-04-17 |
| Date Mfgr Received | 1998-08-04 |
| Date Added to Maude | 1998-09-08 |
| 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 | 0 |
| 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 | BAXTER LIFESPAN EPTFE VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1998-09-03 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 180448 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 23601 RIDGE ROUTE, SUITE C LAGUNA HILLS CA 92653 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-09-03 |