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 2020-03-30 for GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET G52916 IGTCFS-65-1-JUG-TULIP manufactured by William Cook Europe.
| Report Number | 3002808486-2020-00374 |
| MDR Report Key | 9896430 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-03-30 |
| 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 | MR. THOMAS HESSNER KIRK |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-4632 |
| Manufacturer Phone | 56868686 |
| Manufacturer G1 | WILLIAM COOK EUROPE |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-4632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET |
| Generic Name | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Product Code | DTK |
| Date Received | 2020-03-30 |
| Model Number | G52916 |
| Catalog Number | IGTCFS-65-1-JUG-TULIP |
| Lot Number | E3925585 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |