MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-14 for GORE-TEX manufactured by Wl Gore & Assoc.
[28790]
Clotted graft in pt with end stage renal disease.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 50225 |
| MDR Report Key | 50225 |
| Date Received | 1996-11-14 |
| Date of Report | 1996-11-13 |
| Date of Event | 1996-11-12 |
| Date Facility Aware | 1996-11-12 |
| Report Date | 1996-11-13 |
| Date Reported to FDA | 1996-11-13 |
| Date Added to Maude | 1996-11-21 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE-TEX |
| Generic Name | VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1996-11-14 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 113824DC 009 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 50938 |
| Manufacturer | WL GORE & ASSOC |
| Manufacturer Address | 3300 SPARROW P.O. BOX 3200 FLAGSTAFF AZ 860033200 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-11-14 |