Brand Name | NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
MDR Report Key | 13753383 |
MDR Text Key | 287100947 |
Report Number | 6000034-2022-00704 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 09321502032612 |
UDI-Public | (01)09321502032612(11)170118(17)190117 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/14/2022,02/18/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 01/17/2019 |
Device Model Number | CI532 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/28/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/14/2022 |
Distributor Facility Aware Date | 02/18/2022 |
Date Report to Manufacturer | 02/18/2022 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/13/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 5 YR |
Patient Sex | Female |