FDA.reportPublic FDA data

MAUDE MDR 9390954

MDR report key
9390954
Report number
9611109-2019-00926
Event key
0
Event type
3
Date of event
2019-11-01
Date received
2019-11-29
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
ENRICO GRECO
Address
14401 W. 65TH WAY ARVADA CO 80004 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1S5 ROLLER PUMPCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASSLIVANOVA DEUTSCHLAND GMBHDWB10-80-00R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-290

Event Narratives#

No narrative records found.