FDA.reportPublic FDA data

MAUDE MDR 9391747

MDR report key
9391747
Report number
9391747
Event key
0
Event type
3
Date of event
2019-11-18
Date received
2019-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THORATEC? HEARTMATE 3? LVAS IMPLANT KITVENTRICULAR (ASSISST) BYPASSTHORATEC CORPORATIONDSQ106524US106524US* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. D

Event Narratives#

No narrative records found.