FDA.reportPublic FDA data

MAUDE MDR 9171499

MDR report key
9171499
Report number
2245578-2019-00233
Event key
0
Event type
3
Date of event
2019-06-18
Date received
2019-10-09
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
LINDA MACZUSZENKO
Address
400 COLLEGE ROAD PRINCETON NJ 08540 US
Phone
613-613-6136
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1I-STAT EC4+ CARTRIDGEEC4+ CARTRIDGEABBOTT POINT OF CAREJGSNA03P81-25K19010N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-090

Event Narratives#

No narrative records found.