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 | 8592213 |
MDR Text Key | 144460461 |
Report Number | 3006556115-2019-00223 |
Device Sequence Number | 1 |
Product Code |
MCM
|
UDI-Device Identifier | 07630016862250 |
UDI-Public | (01)07630016862250(11)190204(17)220131 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P960058 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/15/2019 |
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 | 01/31/2022 |
Device Model Number | CI-1601-04 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/08/2019 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 06/04/2019 07/15/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/07/2019 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|