MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-19 for GORE-TEX GRAFT manufactured by W.l. Gore & Assoc..
[19921]
End stage renal disease with infected graft right arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 27811 |
| MDR Report Key | 27811 |
| Date Received | 1995-10-19 |
| Date of Report | 1995-10-16 |
| Date of Event | 1995-09-25 |
| Date Facility Aware | 1995-09-25 |
| Report Date | 1995-10-16 |
| Date Reported to FDA | 1995-10-16 |
| Date Reported to Mfgr | 1995-10-16 |
| Date Added to Maude | 1995-11-07 |
| 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 |
| 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 GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1995-10-19 |
| Lot Number | 313404CA-038 |
| ID Number | RD06005045L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 28709 |
| Manufacturer | W.L. GORE & ASSOC. |
| Manufacturer Address | P.O. BOX 3080 FLAGSTAFF AZ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-10-19 |