MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-10-11 for ONYX manufactured by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular.
| Report Number | 2029214-2019-01019 |
| MDR Report Key | 9179383 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-11 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2019-09-17 |
| Date Added to Maude | 2019-10-11 |
| 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 | MGR. KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONYX |
| Generic Name | AGENT, INJECTABLE, EMBOLIC |
| Product Code | MFE |
| Date Received | 2019-10-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-11 |