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 2020-03-31 for POWERFLEX P3 F5 6X4 80 4206040S manufactured by Cordis Cashel.
| Report Number | 9616099-2020-03612 |
| MDR Report Key | 9903558 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-09-28 |
| Date Added to Maude | 2020-03-31 |
| 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 | 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 | POWERFLEX P3 F5 6X4 80 |
| Generic Name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
| Product Code | LIT |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 4206040S |
| Catalog Number | 4206040S |
| Lot Number | 82178602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-31 |