Brand Name | NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT |
Type of Device | NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT |
Manufacturer (Section D) |
COCHLEAR LIMITED |
1 university avenue |
macquarie university |
nsw 2109 |
AS 2109 |
|
Manufacturer (Section G) |
COCHLEAR LTD |
1 university avenue |
|
macquarie university, nsw 2109 |
AS
2109
|
|
Manufacturer Contact |
thanaletchumi
manogaran
|
unit ug-1, vertical podium |
no. 8 jalan kerinchi, |
kuala lumpur, wilayah persekutuan 59200
|
MY
59200
|
|
MDR Report Key | 13851349 |
MDR Text Key | 287661336 |
Report Number | 6000034-2022-00792 |
Device Sequence Number | 1 |
Product Code |
MHE
|
UDI-Device Identifier | 09321502020404 |
UDI-Public | (01)09321502020404(11)151119(17)171118 |
Combination Product (y/n) | N |
Reporter Country Code | TU |
PMA/PMN Number | P000015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/29/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/22/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/18/2017 |
Device Model Number | ABI541 |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/28/2022 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/29/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/19/2015 |
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;
|
Patient Age | 7 YR |
Patient Sex | Female |