MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-14 for 6MM GORETEX GRAFT UNKNOWN manufactured by W.l. Gore & Assoc., Inc..
[14842]
The pt's graft bled 4 days ago and stopped. She was dialyzed on 5/30/95. Pt came to er with forearm bleeding, when the physician opened the wound, a fistula was exposed which bled profusely. Pt was brought to or for graft revision with 2 vascular clamps in place. Graft was implanted approx 10 yrs ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22741 |
| MDR Report Key | 22741 |
| Date Received | 1995-06-14 |
| Date of Report | 1995-05-30 |
| Date of Event | 1995-05-30 |
| Date Facility Aware | 1995-05-30 |
| Report Date | 1995-05-31 |
| Date Added to Maude | 1995-06-23 |
| 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 | 6MM GORETEX GRAFT |
| Product Code | FIQ |
| Date Received | 1995-06-14 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 22938 |
| Manufacturer | W.L. GORE & ASSOC., INC. |
| Manufacturer Address | FLAGSTAFF AZ 860033200 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-06-14 |