Brand Name | NI |
Type of Device | COCHLEAR BAHA CONNECT SYSTEM |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvagen 14 |
molnlycke, 435 3 3 |
SW 435 33 |
|
Manufacturer (Section G) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvagen 14 |
|
molnlycke, 435 3 3 |
SW
435 33
|
|
Manufacturer Contact |
thevamalar
jayamagentharan
|
unit ug-1, vertical podium |
no. 8 jalan kerinchi, |
kuala lumpur, wilayah persekutuan 59200
|
MY
59200
|
|
MDR Report Key | 18515667 |
MDR Text Key | 332868074 |
Report Number | 6000034-2024-00195 |
Device Sequence Number | 1 |
Product Code |
LXB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K100360 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/07/2024 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/20/2023 |
Initial Date FDA Received | 01/16/2024 |
Supplement Dates Manufacturer Received | 02/07/2024
|
Supplement Dates FDA Received | 03/05/2024
|
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 25 YR |
Patient Sex | Female |
|
|