MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-05-03 for D-STAT FLOWABLE HEMOSTAT 4000 * manufactured by Vascular Solutions, Inc..
[627770]
Following a liver biopsy procedure, 5cc of d-stat flowable was injected into the tissue tract of the biopsy access site. The patient tolerated the delivery of the procoagulant without any indication of problems or changes in vital signs; however, when the patient sat up to be transferred into a wheelchair, he became unconscious and coded. The patient was resuscitated, but expired 15 days later. Please note that use of the d-stat flowable product in this manner represented an off-label use of the product.
Patient Sequence No: 1, Text Type: D, B5
[7873182]
Submission of this report does not represent a conclusion or admission by vascular solutions, inc. , that the content of this report is complete or accurate, or that the device failed or malfunctioned in any manner or that the device caused or contributed to a death or serious injury of any person.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134812-2007-00006 |
| MDR Report Key | 845099 |
| Report Source | 05,06,07 |
| Date Received | 2007-05-03 |
| Date of Report | 2007-05-03 |
| Date of Event | 2007-02-22 |
| Date Mfgr Received | 2007-04-18 |
| Date Added to Maude | 2007-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JULIE TAPPER |
| Manufacturer Street | 6464 SYCAMORE CT. |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564228 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-STAT FLOWABLE HEMOSTAT |
| Generic Name | TOPICAL HEMOSTAT |
| Product Code | MHW |
| Date Received | 2007-05-03 |
| Model Number | 4000 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 832281 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | * MINNEAPOLIS MN 55369 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-05-03 |