Brand Name | CP1000 PROCESSING UNIT BULK, GREY |
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 | 10045874 |
MDR Text Key | 190606943 |
Report Number | 6000034-2020-01269 |
Device Sequence Number | 1 |
Product Code |
MCM
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial |
Report Date |
05/12/2020,04/23/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/11/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | N/A |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/12/2020 |
Distributor Facility Aware Date | 04/23/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|