Brand Name | COCHLEAR IMPLANT |
Type of Device | Implant, cochlear |
Manufacturer (Section D) |
OTICON MEDICAL - NEURELEC |
2720, chemin saint-bernard |
porte 14 |
vallauris, 06220 |
FR 06220 |
|
Manufacturer Contact |
charlotte
desbrosse
|
2720, chemin saint-bernard |
porte 14 |
vallauris, 06220
|
FR
06220
|
|
MDR Report Key | 18245893 |
MDR Text Key | 329478610 |
Report Number | 3016743107-2023-00028 |
Device Sequence Number | 1 |
Product Code |
MCM
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | P200021 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/01/2023 |
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? |
Yes
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/02/2023
|
Initial Date FDA Received | 12/01/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|