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 2020-02-27 for COBRA PZF 170-02-35015 manufactured by Celonova Biosciences, Inc..
| Report Number | 3009306400-2020-00012 |
| MDR Report Key | 9764736 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2016-10-11 |
| Date Added to Maude | 2020-02-27 |
| 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 | MR. ERICK ZUMAYA |
| Manufacturer Street | 5840 EL CAMINO REAL SUITE 111 |
| Manufacturer City | CARLSABAD, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6035619 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBRA PZF |
| Generic Name | STENT CORONARY DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-02-27 |
| Model Number | NA |
| Catalog Number | 170-02-35015 |
| Lot Number | 1610114001 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELONOVA BIOSCIENCES, INC. |
| Manufacturer Address | 5840 EL CAMINO REAL SUITE 111 CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |