FDA Adverse Event
Injury
Summary report: N
D-STAT FLOWABLE HEMOSTAT
MDR report key: 409230
·
Received August 8, 2002
Report
- Report Number
- 2134812-2002-00311
- Event Type
- Injury
- Date Received
- August 8, 2002
- Date of Event
- July 12, 2002
- Report Date
- August 8, 2002
- Manufacturer
- VASCULAR SOLUTIONS, INC.
- Product Code
- MHW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IN A PROCEDURE OCCURING IN THE EUROPEAN ECONOMIC AREA, ONE ML OF D-STAT FLOWABLE HEMOSTAT WAS INJECTED INTO A PSEUDOANEURYSM. THIS IS AN APPROVED INDICATION FOR USE IN THE EUROPEAN ECONOMIC AREA. TWO HOURS AFTER THE INJECTION, THE PATIENT DEVELOPED SYSMPTOMS INCLUDING A COLD, WHITE LEG, WHICH WAS DIAGNOSED AS AN ARTERIAL OCCLUSION. A SURGICAL THROMBECTOMY WAS PERFORMED. THE EVENT WAS RESOLVED WITH NO FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | D-STAT FLOWABLE HEMOSTAT | TOPICAL HEMOSTAT | MHW | VASCULAR SOLUTIONS, INC. | 4000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |