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 |
lacey
mcdonald
|
28515 westinghouse place |
valencia, CA 91355
|
|
MDR Report Key | 11388731 |
MDR Text Key | 238398229 |
Report Number | 3006556115-2021-00164 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 07630016861772 |
UDI-Public | (01)07630016861772(11)181121(17)211130 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P960058 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/02/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/26/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/30/2021 |
Device Model Number | CI-1601-04 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/26/2018 |
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 |