Brand Name | CP1150 HOME CHARGER |
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 | 15459943 |
MDR Text Key | 300293888 |
Report Number | 6000034-2022-02780 |
Device Sequence Number | 1 |
Product Code |
MCM
|
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
|
Type of Report
| Initial |
Report Date |
09/21/2022,08/31/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/20/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | CP1150 |
Device Catalogue Number | P1434277 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/21/2022 |
Distributor Facility Aware Date | 08/31/2022 |
Date Report to Manufacturer | 08/31/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Female |
|
|