MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-13 for DIASTAT VASCULAR ACCESS GRAFT D47150 manufactured by W.l. Gore & Associates, Inc..
[11380]
Removal of vascular graft from left arm due to problems of repeated rethrombosis after declotting procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005600 |
| MDR Report Key | 21145 |
| Date Received | 1995-04-13 |
| Date of Report | 1995-04-04 |
| Date of Event | 1995-03-24 |
| Date Added to Maude | 1995-04-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIASTAT VASCULAR ACCESS GRAFT |
| Generic Name | VASCULAR ACCESS GRAFT |
| Product Code | FIQ |
| Date Received | 1995-04-13 |
| Model Number | D47150 |
| Lot Number | 112549 BAA-006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 21119 |
| Manufacturer | W.L. GORE & ASSOCIATES, INC. |
| Manufacturer Address | FLAGSTAFF AZ 86001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-04-13 |