FDA.reportPublic FDA data

MAUDE MDR 9822018

MDR report key
9822018
Report number
3005687633-2020-00106
Event key
0
Event type
3
Date of event
2016-08-24
Date received
2020-03-11
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
MS FRANCESCA CROVATO
Address
5005 NORTH FRASER WAY BURNABY, BRITISH COLUMBIA V5J5M CA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CARBOMEDICS TOP HAT MECHANICAL HEART VALVEMECHANICAL HEART VALVE PROSTHESISSORIN GROUP ITALIA S.R.L.LWQS5-021S5-021R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1101. R

Event Narratives#

No narrative records found.