FDA.reportPublic FDA data

MAUDE MDR 9324862

MDR report key
9324862
Report number
6000034-2019-02378
Event key
0
Event type
3
Date of event
2019-09-10
Date received
2019-11-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. ROBERTA LOVEDAY
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
1COCHLEAR OSIA OSI100 IMPLANTCOCHLEAR BAHA CONNECT SYSTEMCOCHLEAR BONE ANCHORED SOLUTIONS ABPFOR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-1401. R

Event Narratives#

No narrative records found.