MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2009-12-01 for D-STAT FLOWABLE 4000 manufactured by Vascular Solutions, Inc..
[1253427]
Patient contacted customer service reporting that she had a liver biopsy, experienced pain, and received pain medication. The patient contacted the manufacturer for product information.
Patient Sequence No: 1, Text Type: D, B5
[8323221]
Upon receipt of the reported event by the patient, a representative of the manufacturer contacted doctor's hospital at (b)(6) in (b)(6). The hospital confirmed that they had a female patient who received a liver biopsy at the same time as the patient who contacted the manufacturer. The hospital confirmed that d-stat flowable was used for a liver biopsy, the patient experienced pain and was given pain medication. No other additional information was obtained. The instructions for use for d-stat flowable include the following statement: "the safety and effectiveness of d-stat has not been established for use to control bleeding following organ or tissue biopsies. Use of d-stat in this situation has been reported to result in pain, seizures, bile retention, tissue necrosis, vascular occlusion and death. " it is manufacturer's conclusion that the use of d-stat flowable for a liver biopsy is an off-label use of the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134812-2009-00035 |
| MDR Report Key | 1548260 |
| Report Source | 00,07 |
| Date Received | 2009-12-01 |
| Date of Report | 2009-12-01 |
| Date of Event | 2009-11-02 |
| Date Mfgr Received | 2009-11-02 |
| Date Added to Maude | 2010-10-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS STACY OUELLETTE |
| Manufacturer Street | 6464 SYCAMORE COURT |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564300 |
| Manufacturer G1 | VASCULAR SOLUTIONS, INC. |
| Manufacturer Street | 6464 SYCAMORE COURT |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55369 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-STAT FLOWABLE |
| Generic Name | HEMOSTAT |
| Product Code | MHW |
| Date Received | 2009-12-01 |
| Model Number | 4000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | 6464 SYCAMORE COURT MINNEAPOLIS MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-01 |