Brand Name | CP1110 PROCESSING UNIT |
Type of Device | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
Manufacturer (Section G) |
COCHLEAR LTD |
1 university avenue |
|
macquarie university, nsw 2109 |
AS
2109
|
|
Manufacturer Contact |
debbie
ang
|
unit ug-1, vertical podium |
no.8 jalan kerinchi |
kuala lumpur, wilayah persekutuan 59200
|
MY
59200
|
|
MDR Report Key | 18299201 |
MDR Text Key | 330110970 |
Report Number | 6000034-2023-03966 |
Device Sequence Number | 1 |
Product Code |
MCM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970051 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/17/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/11/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | CP1110 |
Device Catalogue Number | P1840332 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/17/2023 |
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |
|
|