FDA.reportPublic FDA data

MAUDE MDR 9908856

MDR report key
9908856
Report number
6000034-2020-00940
Event key
0
Event type
3
Date of event
2020-03-10
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KRISTEL KOHNE
Address
1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109, AS
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODENUCLEUS 24 COCHLEAR IMPLANT SYSTEMCOCHLEAR LTDMCMCI512NANAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

No narrative records found.