MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-05-03 for D-STAT FLOWABLE HEMOSTAT 4000 * manufactured by Vascular Solutions, Inc..
[19951417]
The following information was relayed to vascular solutions by fda in a letter dated 04/23/2007. A pt underwent an abdominal lymph node biopsy procedure using a 19 gauge needle. D-stat flowable was used in the tissue tract, and minutes later the pt experienced severe abdominal pain. Two days later, a 6-foot segment of small bowel was removed and the pathology showed a normal bowel that was gangrenous. The reporting party was concerned that d-stat flowable was delivered intra-arterially. 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
[20076718]
The device was used for an unapproved indication.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134812-2007-00007 |
| MDR Report Key | 847101 |
| Report Source | 00 |
| Date Received | 2007-05-03 |
| Date of Report | 2007-05-03 |
| Date of Event | 2007-02-15 |
| Date Mfgr Received | 2007-04-18 |
| Date Added to Maude | 2007-05-15 |
| 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 | 826369 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | * MINNEAPOLIS MN 55369 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2007-05-03 |