Brand Name | BI300 IMPLANT 4 MM |
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 BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
po box 82 |
mölnlycke 43533 |
SW
43533
|
|
Manufacturer Contact |
tamara
martin
|
1 university avenue |
macquarie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 8481150 |
MDR Text Key | 140872398 |
Report Number | 6000034-2019-00476 |
Device Sequence Number | 1 |
Product Code |
LXB
|
UDI-Device Identifier | 09321502019545 |
UDI-Public | (01)09321502019545(10)COH1117229(17)220411 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K100360 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/12/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/03/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/11/2022 |
Device Model Number | 92129 |
Device Catalogue Number | 92129 |
Device Lot Number | COH1117229 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/12/2019 |
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) |
Hospitalization;
Required Intervention;
|