FDA.reportPublic FDA data

MAUDE MDR 9695211

MDR report key
9695211
Report number
3008344661-2020-00014
Event key
0
Event type
3
Date of event
2019-12-03
Date received
2020-02-11
Adverse event
0
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 TOTAL PSA REAGENT KITPROSTATIC SPECIFIC ANTIGEN (PSA)ABBOTT IRELAND DIAGNOSTICS DIVISIONMTF07P92-30UNKNOWNY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-110

Event Narratives#

No narrative records found.