MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-29 for 466FXXXX manufactured by Cordis Cashel.
| Report Number | 1016427-2019-03612 |
| MDR Report Key | 9391853 |
| Report Source | OTHER |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-11-07 |
| Date Added to Maude | 2019-11-29 |
| 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 | MRS. KARLA CASTRO |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863138372 |
| Manufacturer G1 | CORDIS CASHEL |
| Manufacturer Street | CAHIR ROAD CASHEL, CO. TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 466FXXXX |
| Generic Name | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Product Code | DTK |
| Date Received | 2019-11-29 |
| Model Number | 466FXXXX |
| Catalog Number | 466FXXXX |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CASHEL |
| Manufacturer Address | CAHIR ROAD CASHEL, CO. TIPPERARY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-11-29 |