Brand Name | NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
Manufacturer Contact |
bianca
pries
|
1 university avenue |
macquarie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 7140203 |
MDR Text Key | 95581394 |
Report Number | 6000034-2017-02430 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502032599 |
UDI-Public | (01)09321502032599(11)160531(17)180530 |
Combination Product (y/n) | N |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial |
Report Date |
11/28/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/21/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 05/30/2018 |
Device Model Number | CI522 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/28/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/31/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|