MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-02 for DRASTAT VASCULAR GRAFT 6MMX30CM D06002 manufactured by W.l. Gore & Assoc., Inc..
[21029]
Pt was last dialyzed 7/31/95. Clotted access noted 8/2/95. Removal of portion of graft that was blocked, hard to touch. Noted ring-like thread fibers around portion of graft. Sent to pathology with clot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30805 |
| MDR Report Key | 30805 |
| Date Received | 1996-02-02 |
| Date of Report | 1995-08-02 |
| Date of Event | 1995-08-02 |
| Date Facility Aware | 1995-08-02 |
| Report Date | 1995-08-02 |
| Date Added to Maude | 1996-03-07 |
| 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 | DRASTAT VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | MCI |
| Date Received | 1996-02-02 |
| Model Number | 6MMX30CM |
| Catalog Number | D06002 |
| Lot Number | 313073BBA-036 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 5 MO |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31862 |
| Manufacturer | W.L. GORE & ASSOC., INC. |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-02-02 |