FDA.reportPublic FDA data

MAUDE MDR 9328438

MDR report key
9328438
Report number
1823260-2019-04082
Event key
0
Event type
3
Date of event
2019-09-20
Date received
2019-11-15
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
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CA 19-9 ELECSYS E2GCARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEMROCHE DIAGNOSTICSNIGCA 19-9 ELECSYS E2G0702702819041624500, 41624501R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-150

Event Narratives#

No narrative records found.