FDA Adverse Event
Malfunction
Summary report: N
HEMASHIELD KNITTED DOUBLE VELOUR FABRIC
MDR report key: 256546
·
Received December 16, 1999
Report
- Report Number
- 6000072-1999-00084
- Event Type
- Malfunction
- Date Received
- December 16, 1999
- Date of Event
- November 18, 1999
- Report Date
- November 19, 1999
- Manufacturer
- BOSTON SCIENTIFIC/VASCULAR
- Product Code
- DXZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE DR CLAIMS THAT THE FABRIC WAS IMPLANTED FOR A CAROTID ARTERY PROCEDURE AND LEAKED BLOOD (QUANTITY UNK). THE BLOOD CLOTTED AND THE LEAKAGE STOPPED. THE PROCEDURE OUTCOME WAS FINE. THE PT'S CONDITION WAS FINE. NOTE: ON 11/25/1999, CO LEARNED THAT THE BLEEDING WAS STOPPED WITH 5 RAYTEX PATCHES AND 6 SUTURES. THE QUANTITY OF BLOOD LOST THROUGH THE PATCH IS UNK AND UNATTAINABLE. THE PATCH WAS LEFT IN. NOTE: ON 12/7/1999, CO LEARNED THAT THE INCIDENT DATE WAS 11/18/1999, AND THE PROCEDURE WAS A CAROTID ENDARTERECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMASHIELD KNITTED DOUBLE VELOUR FABRIC Implant | CARDIOVASCULAR FABRIC | DXZ | BOSTON SCIENTIFIC/VASCULAR | 019508 | 2326573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |