FDA.reportPublic FDA data

MAUDE MDR 9872465

MDR report key
9872465
Report number
2029214-2020-00289
Event key
0
Event type
3
Date of event
2020-02-16
Date received
2020-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MGR. KATCHA TAYLOR
Address
9775 TOLEDO WAY IRVINE CA 92618 US
Phone
949-949-9496
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ONYXAGENT, INJECTABLE, EMBOLICMICRO THERAPEUTICS, INC. DBA EV3MFEUNKNOWNNOT REPORTEDN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2401. R

Event Narratives#

No narrative records found.