MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-03 for GUARDIAN II 8210 manufactured by Vascular Solutions, Llc.
| Report Number | 2134812-2019-00065 |
| MDR Report Key | 9151675 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-03 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-08-22 |
| Date Mfgr Received | 2019-09-22 |
| Device Manufacturer Date | 2019-02-27 |
| Date Added to Maude | 2019-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MARY HAUFEK |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564230 |
| Manufacturer G1 | VASCULAR SOLUTIONS, LLC |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| 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 | GUARDIAN II |
| Generic Name | HEMOSTASIS VALVE |
| Product Code | DTL |
| Date Received | 2019-10-03 |
| Returned To Mfg | 2019-09-13 |
| Model Number | 8210 |
| Lot Number | 54581 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS, LLC |
| Manufacturer Address | 6464 SYCAMORE COURT NORTH MINNEAPOLIS MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-03 |