FDA.reportPublic FDA data

MAUDE MDR 9263971

MDR report key
9263971
Report number
6000034-2019-02211
Event key
0
Event type
3
Date received
2019-10-31
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 ABI541 AUDITORY BRAINSTEM IMPLANTNUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEMCOCHLEAR LTDMHEABI541NANAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-3101. R

Event Narratives#

No narrative records found.