FDA.reportPublic FDA data

MAUDE MDR 9391973

MDR report key
9391973
Report number
3004478276-2019-00321
Event key
0
Event type
3
Date of event
2019-08-26
Date received
2019-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
FRANCESCA CROVATO
Address
5005 N FRASER WAY BURNABY, BC V5J 5 CA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERCEVAL SUTURELESS AORTIC HEART VALVETISSUE HEART VALVELIVANOVA CANADA CORP.LWRPVS23ICV1209R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. R; 2. S

Event Narratives#

No narrative records found.