MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-08 for OUTBACK ELITE 80CM RE-ENTRY OTB59080A manufactured by Cordis Corporation.
| Report Number | 9616099-2019-03260 |
| MDR Report Key | 9166990 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-08 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-09-05 |
| Date Mfgr Received | 2019-11-08 |
| Device Manufacturer Date | 2019-04-05 |
| Date Added to Maude | 2019-10-08 |
| 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 CORPORATION |
| Manufacturer Street | 14201 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTBACK ELITE 80CM RE-ENTRY |
| Generic Name | CATHETER FOR CROSSING TOTAL OCCLUSIONS |
| Product Code | PDU |
| Date Received | 2019-10-08 |
| Catalog Number | OTB59080A |
| Lot Number | 17850680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 NW 60TH AVE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-08 |