FDA.reportPublic FDA data

MAUDE MDR 9801769

MDR report key
9801769
Report number
2015691-2020-10842
Event key
0
Event type
3
Date of event
2020-02-19
Date received
2020-03-06
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
1FORESIGHT ELITE ABSOLUTE TISSUE OXIMETERFORESIGHT ELITE TISSUE OXIMETER MONITOREDWARDS LIFESCIENCESMUD01-06-3000N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-060

Event Narratives#

No narrative records found.