FDA.reportPublic FDA data

MAUDE MDR 9908588

MDR report key
9908588
Report number
2015691-2020-11253
Event key
0
Event type
3
Date of event
2020-03-10
Date received
2020-03-31
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
MRS. RENEE DORNE
Address
1 EDWARDS WAY IRVINE CA 92614 US
Phone
949-949-9492
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EDWARDS EXPANDABLE INTRODUCER SHEATH SETAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVEREDEDWARDS LIFESCIENCESNPT914ESAN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

No narrative records found.