FDA Adverse Event
Injury
Summary report: N
HEMASHIELD KNITTED DOUBLE VELOUR FABRIC
MDR report key: 117523
·
Received September 3, 1997
Report
- Report Number
- 2242352-1997-00070
- Event Type
- Injury
- Date Received
- September 3, 1997
- Date of Event
- June 18, 1997
- Report Date
- August 5, 1997
- Manufacturer
- MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
- Product Code
- DXZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE FABRIC WAS IMPLANTED AS A CAROTID PATCH. AT THE END OF THE PROCEDURE, THE HEPARIN WAS REVERSED WITH PROTAMINE. APPROXIMATELY 1-2 HOURS AFTER SURGERY, THE PT DEVELOPED A STROKE. AND EXPERIENCED UPPER EXTREMITY DISABILITY. THE PT WAS SUBSEQUENTLY PLACED INTO A REHABILITATION PROGRAM. THE FABRIC REMAINS IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMASHIELD KNITTED DOUBLE VELOUR FABRIC Implant | CARDIOVASCULAR FABRIC | DXZ | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. | 019508 | 146366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization| S | REHABILITATION SUBSEQUENT TO SURGERY DATE UNKNOWN. |