MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-31 for DIALYSIS GRAFT IN RIGHT LEG V06070L manufactured by W.l. Gore & Assoc., Inc..
[18804]
Removal of infected right leg dialysis graft. Pt with known problems in past of perm catheters needing replaced. 1/96 with sepsis and removal of right perm catheter. Left upper catheter non-functioning due to severe ischemia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33728 |
| MDR Report Key | 33728 |
| Date Received | 1996-05-31 |
| Date of Report | 1996-05-29 |
| Date of Event | 1996-05-14 |
| Date Facility Aware | 1996-05-14 |
| Report Date | 1996-05-29 |
| Date Reported to FDA | 1996-05-29 |
| Date Reported to Mfgr | 1996-05-29 |
| Date Added to Maude | 1996-07-01 |
| 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 | DIALYSIS GRAFT IN RIGHT LEG |
| Generic Name | VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1996-05-31 |
| Model Number | V06070L |
| Lot Number | 31 3869AC-040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 35079 |
| Manufacturer | W.L. GORE & ASSOC., INC. |
| Manufacturer Address | FLAGSTAFF AZ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-05-31 |