Brand Name | FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT |
Type of Device | COCHLEAR BAHA CONNECT SYSTEM |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
mölnlycke, 435 3 3 |
SW 435 33 |
|
Manufacturer (Section G) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
|
mölnlycke, 435 3 3 |
SW
435 33
|
|
Manufacturer Contact |
kohilah
nadaraja
|
unit ug-1, vertical podium |
no. 8 jalan kerinchi, |
kuala lumpur, wilayah persekutuan 59200
|
MY
59200
|
|
MDR Report Key | 18957557 |
MDR Text Key | 338302373 |
Report Number | 6000034-2024-01014 |
Device Sequence Number | 1 |
Product Code |
LXB
|
UDI-Device Identifier | 09321502014359 |
UDI-Public | (01)09321502014359(10)COH185718(17)160101 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K955713 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/28/2024 |
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
|
Device Expiration Date | 01/01/2016 |
Device Model Number | 90434 |
Device Catalogue Number | 90434 |
Device Lot Number | COH185718 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/28/2024
|
Initial Date FDA Received | 03/22/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 | 78 YR |
Patient Sex | Male |