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 2020-03-14 for AZUR 35 HYDROCOIL DETACHABLE 10MM X 20CM 45-451020 manufactured by Microvention, Inc..
| Report Number | 2032493-2020-00064 |
| MDR Report Key | 9832967 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-01-04 |
| Date Added to Maude | 2020-03-14 |
| 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 | MS. EVA MANUS |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AZUR 35 HYDROCOIL DETACHABLE 10MM X 20CM |
| Generic Name | VASCULAR EMBOLIZATION DEVICE |
| Product Code | KRD |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 45-451020 |
| Catalog Number | 45-451020 |
| Lot Number | 19010453F |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 35 ENTERPRISE ALISO VIEJO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-14 |