Brand Name | UNKNOWN |
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 Contact |
bianca
hanlon
|
1 university avenue |
macqaurie university, nsw 2109
|
AS
2109
|
94286555
|
|
MDR Report Key | 6153157 |
MDR Text Key | 61696014 |
Report Number | 6000034-2016-02338 |
Device Sequence Number | 1 |
Product Code |
LXB
|
Combination Product (y/n) | N |
PMA/PMN Number | UNKNOWN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
Type of Report
| Initial,Followup |
Report Date |
12/08/2016 |
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 | UNKNOWN |
Device Catalogue Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/11/2016 |
Initial Date FDA Received | 12/07/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/18/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|