FDA.reportPublic FDA data

MAUDE MDR 9908495

MDR report key
9908495
Report number
3007042319-2020-02776
Event key
0
Event type
3
Date of event
2020-03-28
Date received
2020-03-31
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
PAULA BIXBY
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0VENTRICULAR (ASSIST) BYPASSHEARTWARE, INC.DSQ1420-CONTROLLER1420-CONTROLLER* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

No narrative records found.