Brand Name | HIRES ULTRA 3D IMPLANT |
Type of Device | COCHLEAR IMPLANT |
Manufacturer (Section D) |
ADVANCED BIONICS, LLC |
28515 westinghouse place |
valencia CA 91355 |
|
Manufacturer Contact |
brooke
lopez
|
28515 westinghouse place |
valencia, CA 91355
|
|
MDR Report Key | 10860544 |
MDR Text Key | 216904878 |
Report Number | 3006556115-2020-01412 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 07630016872037 |
UDI-Public | (01)07630016872037(11)190905(17)220731 |
Combination Product (y/n) | N |
Reporter Country Code | DE |
PMA/PMN Number | P960058 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/11/2020 |
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 | 07/31/2022 |
Device Model Number | CI-1601-05 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/18/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/05/2019 |
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 |
|
|