Brand Name | NUCLEUS HYBRID L24 |
Type of Device | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM |
Manufacturer (Section D) |
COCHLEAR LTD |
1 university avenue |
macquarie university, nsw 2109 |
AS 2109 |
|
Manufacturer Contact |
sujeewa
wijesinghe
|
1 university avenue |
macquarie university, nsw 2109,
|
AS
2109,
|
|
MDR Report Key | 7258525 |
MDR Text Key | 99566072 |
Report Number | 6000034-2018-00379 |
Device Sequence Number | 1 |
Product Code |
PGQ
|
UDI-Device Identifier | 09321502012089 |
UDI-Public | (01)09321502012089(11)140730(17)160729 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P130016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Audiologist
|
Type of Report
| Initial |
Report Date |
01/31/2018 |
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 | 07/29/2016 |
Device Model Number | CI24RE (L24) |
Device Catalogue Number | N/A |
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
|
Initial Date Manufacturer Received |
01/31/2018 |
Initial Date FDA Received | 02/09/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/30/2014 |
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;
|
|
|