FDA Adverse Event
Malfunction
Summary report: N
HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT
MDR report key: 57468
·
Received December 17, 1996
Report
- Report Number
- 2242352-1996-00079
- Event Type
- Malfunction
- Date Received
- December 17, 1996
- Date of Event
- November 22, 1996
- Report Date
- November 25, 1996
- Manufacturer
- MEADOX MEDICALS, INC, DIV BSC
- Product Code
- MAL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE GRAFT WAS IMPLANTED FOR AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. AFTER DECLAMPING, THE GRAFT LEAKED APPROX 1000CC (ESTIMATED, EXACT QUANTITY UNKNOWN) OF BLOOD THROUGHOUT ITS WALLS. THE GRAFT BECAME BLOOD-TIGHT AFTER APPROX 30 MINUTES BY THE APPLICATION OF PRESSURE. THE GRAFT WAS LEFT IN. NO INJURY TO THE PT WAS REPORTED. THE PT'S CONDITION IS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant | SEALED VASCULAR GRAFT | MAL | MEADOX MEDICALS, INC, DIV BSC | 085201 | 036153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |