MAUDE MDR 8796751

MDR report key
8796751
Report number
3002809144-2019-00441
Event key
0
Event type
3
Date received
2019-07-16
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
NOEMI ROMERO-KONDOS, RN BSN
Address
100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 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 BNP CALIBRATORSBNP CALIBRATORSABBOTT GERMANYJIT08K28-0344K79418Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-160

Event Narratives#

No narrative records found.