Brand Name | ASKU |
Type of Device | COCHLEAR BAHA CONNECT SYSTEM |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
po box 82 |
mölnlycke, 435 2 2 |
SW 435 22 |
|
Manufacturer (Section G) |
COCHLEAR LIMITED |
1 university avenue |
macquarie university |
nsw 2109 |
AS
2109
|
|
Manufacturer Contact |
belinder
gill
|
unit ug-1, vertical podium |
no.8 jalan kerinchi, |
kuala lumpur, wilayah persekutuan 59200
|
MY
59200
|
|
MDR Report Key | 10023286 |
MDR Text Key | 189841599 |
Report Number | 6000034-2020-01324 |
Device Sequence Number | 1 |
Product Code |
LXB
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | NI |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
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 Model Number | ASKU |
Device Catalogue Number | ASKU |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/21/2020 |
Initial Date FDA Received | 05/05/2020 |
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;
|