FDA.reportPublic FDA data

MAUDE MDR 9392248

MDR report key
9392248
Report number
3002809144-2019-00987
Event key
0
Event type
3
Date of event
2019-08-27
Date received
2019-11-30
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
1ALINITY I PROCESSING MODULEAUTOMATED IMMUNOASSAY ANALYZER,ABBOTT GERMANYJJE03R65-01Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-300

Event Narratives#

No narrative records found.