Brand Name | NEURO ZTI COCHLEAR IMPLANT |
Type of Device | NEURO ZTI CLA |
Manufacturer (Section D) |
OTICON MEDICAL - NEURELEC |
2720, chemin saint-bernard |
porte 14 |
vallauris, 06220 |
FR 06220 |
|
Manufacturer (Section G) |
OTICON MEDICAL - NEURELEC |
2720, chemin saint-bernard |
porte 14 |
vallauris, 06220 |
FR
06220
|
|
Manufacturer Contact |
adrian
ternisien
|
2720, chemin de saint-bernard |
porte 14 |
vallauris, 06220
|
FR
06220
|
|
MDR Report Key | 18425525 |
MDR Text Key | 332603817 |
Report Number | 3016743107-2024-00002 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 03663227801842 |
UDI-Public | (01)03663227801842(11)210111(17)240111 |
Combination Product (y/n) | N |
Reporter Country Code | PK |
PMA/PMN Number | P200021 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/02/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 01/11/2024 |
Device Model Number | NEURO ZTI CLA |
Device Catalogue Number | M80184 |
Device Lot Number | 21-00112 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/03/2023
|
Initial Date FDA Received | 01/02/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/11/2021 |
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 |