MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-18 for D-STAT 4000 * manufactured by Vascular Solutions.
[1616049]
Product was opened to use and it did not mix appropriately. Unable to use on patient. Had to open another one to use. This product was never used on patient and did not have any interaction with the patient. Product did not mix properly and did not thicken. ====================== health professional's impression======================does not know.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1705485 |
| MDR Report Key | 1705485 |
| Date Received | 2010-05-18 |
| Date of Report | 2010-05-18 |
| Date of Event | 2010-05-14 |
| Report Date | 2010-05-18 |
| Date Reported to FDA | 2010-05-18 |
| Date Added to Maude | 2010-06-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-STAT |
| Generic Name | FLOWABLE HEMOSTAT |
| Product Code | MHW |
| Date Received | 2010-05-18 |
| Model Number | 4000 |
| Catalog Number | * |
| Lot Number | 547958 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS |
| Manufacturer Address | 6464 SYCAMORE COURT MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-18 |