FDA.reportPublic FDA data

MAUDE MDR 9117783

MDR report key
9117783
Report number
3004634229-2019-00003
Event key
0
Event type
3
Date of event
2019-08-27
Date received
2019-09-25
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
MS. VICKI MCKEE
Address
3 CORPORATE DRIVE LAKE ZURICH IL 60047 US
Phone
847-847-8475
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CATSMARTCATSMART ATF 40 FAST START KIT WITH AT3FRESENIUS HEMOCARE GMBHCACN/A9108493IBT 203Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-250

Event Narratives#

No narrative records found.