Brand Name | HIRES 90K¿ IMPLANT |
Type of Device | COCHLEAR IMPLANT |
Manufacturer (Section D) |
ADVANCED BIONICS, LLC |
28515 westinghouse place |
valencia CA 91355 |
|
Manufacturer Contact |
delilah
garcia
|
28515 westinghouse place |
valencia, CA 91355
|
6613624711
|
|
MDR Report Key | 7152046 |
MDR Text Key | 96061025 |
Report Number | 3006556115-2017-00699 |
Device Sequence Number | 1 |
Product Code |
MCM
|
Combination Product (Y/N) | N |
Reporter Country Code | IN |
PMA/PMN Number | P960058 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
CONSUMER,FOREIGN |
Reporter Occupation |
PATIENT
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
12/01/2017 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 12/28/2017 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
LAY USER/PATIENT
|
Device EXPIRATION Date | 10/31/2014 |
Device MODEL Number | CI-1400-01 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 03/03/2018 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 10/26/2012 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|