FDA.reportPublic FDA data

MAUDE MDR 8724685

MDR report key
8724685
Report number
2015691-2019-02291
Event key
0
Event type
3
Date of event
2019-05-29
Date received
2019-06-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS LYNN THOMAS
Address
ONE EDWARDS WAY IRVINE CA 92614 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EV1000 FLOTRAC CABLEEV1000 FLOTRAC CABLEEDWARDS LIFESCIENCESDXGEVFTCLEVFTCLR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-210

Event Narratives#

No narrative records found.