FDA.reportPublic FDA data

MAUDE MDR 9526086

MDR report key
9526086
Report number
3002809144-2019-01092
Event key
0
Event type
3
Date of event
2019-12-11
Date received
2019-12-27
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
CHRISTIAN LEE
Address
100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 ABBOTT PARK IL 60064 US
Phone
224-224-2246
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCHITECT CA 19-9XRCA 19-9ABBOTT GMBHNIG2K91-3302K91-3305024M800Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-270

Event Narratives#

No narrative records found.