MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-04 for NIT-OCCLUD PDA 145054V2 manufactured by Pfm Medical Ag.
| Report Number | 2032582-2020-00001 |
| MDR Report Key | 9668243 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2019-11-14 |
| Device Manufacturer Date | 2017-12-17 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TROY TAYLOR |
| Manufacturer Street | 1916 PALOMAR OAKS WAY SUITE 150 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7607588749 |
| Manufacturer G1 | PFM MEDICAL AG |
| Manufacturer Street | WANKELSTRASSE 60 |
| Manufacturer City | 50996 COLOGNE, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIT-OCCLUD PDA |
| Generic Name | PDA OCCLUDER |
| Product Code | MAE |
| Date Received | 2020-02-04 |
| Model Number | 145054V2 |
| Catalog Number | 145054V2 |
| Lot Number | 1023387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFM MEDICAL AG |
| Manufacturer Address | WANKELSTRASSE 60 50996 COLOGNE, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |