MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-13 for ONYX AVM 105-7100-060 manufactured by Micro Therapeutics, Inc. Dba Ev3.
Report Number | 2029214-2020-00142 |
MDR Report Key | 9706918 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-02-13 |
Date of Report | 2020-02-13 |
Date of Event | 2020-02-13 |
Date Mfgr Received | 2020-02-13 |
Device Manufacturer Date | 2019-10-02 |
Date Added to Maude | 2020-02-13 |
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. DBA EV3 |
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 AVM |
Generic Name | AGENT, INJECTABLE, EMBOLIC |
Product Code | MFE |
Date Received | 2020-02-13 |
Model Number | 105-7100-060 |
Lot Number | A907932 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-02-13 |