MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-04-14 for VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT 4000 0330 manufactured by Vascular Solutions, Inc..
[15372954]
The d-stat flowable hemostat was deployed to seal the tissue tract following a liver biopsy. The pt immediately experienced a seizure. The pt's vital statistics were monitored until the event was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2003-00377 |
| MDR Report Key | 453772 |
| Report Source | 05,07 |
| Date Received | 2003-04-14 |
| Date of Report | 2003-04-14 |
| Date of Event | 2003-03-18 |
| Date Mfgr Received | 2003-03-18 |
| Date Added to Maude | 2003-04-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BUSKLEIN, SR. ASSOCIATE |
| Manufacturer Street | 6464 SYCAMORE COURT |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT |
| Generic Name | TOPICAL HEMOSTAT |
| Product Code | MHW |
| Date Received | 2003-04-14 |
| Model Number | 4000 |
| Catalog Number | 0330 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 442774 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | 6464 SYCAMORE COURT MINNEAPOLIS MN 55369 US |
| Baseline Brand Name | D-STAT FLOWABLE HEMOSTAT |
| Baseline Generic Name | TOPICAL HEMOSTAT |
| Baseline Model No | 4000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9900 |
| Baseline 510K PMN | Y |
| Premarket Notification | K012293 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-04-14 |