Brand Name | COCHLEAR NUCLEUS CP1000 ACCESSORIES |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS
2109
|
|
Manufacturer Contact |
sujeewa
wijesinghe
|
1 university avenue |
macqaurie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 7140973 |
MDR Text Key | 95580951 |
Report Number | 6000034-2017-02381 |
Device Sequence Number | 1 |
Product Code |
MCM
|
Combination Product (Y/N) | N |
Reporter Country Code | BE |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
HEALTH PROFESSIONAL |
Reporter Occupation |
AUDIOLOGIST
|
Type of Report
| Initial,Followup |
Report Date |
12/26/2017 |
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 MODEL Number | CP1000 |
Device Catalogue Number | Z544854 |
Device LOT Number | N/A |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 12/26/2017 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
|
Patient TREATMENT DATA |
Date Received: 12/21/2017 Patient Sequence Number: 1 |
|
|