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 2020-03-19 for LANGSTON 5540 manufactured by Vascular Solutions, Llc.
| Report Number | 2134812-2020-00026 |
| MDR Report Key | 9853363 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-11-06 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Manufacturer Contact | MS. MARY HAUFEK |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 6564230 |
| Manufacturer G1 | VASCULAR SOLUTIONS, LLC |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LANGSTON |
| Generic Name | DUEL LUMEN |
| Product Code | DQO |
| Date Received | 2020-03-19 |
| Model Number | 5540 |
| Catalog Number | 5540 |
| Lot Number | 661139 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS, LLC |
| Manufacturer Address | 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |