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 |
43533 |
SW
43533
|
|
Manufacturer Contact |
yi
feng
|
1 university avenue |
macquarie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 8978024 |
MDR Text Key | 157040241 |
Report Number | 6000034-2019-01691 |
Device Sequence Number | 1 |
Product Code |
LXB
|
UDI-Device Identifier | 09321502022729 |
UDI-Public | (01)09321502022729(10)136036(17)180531 |
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 |
Report Date |
09/09/2019,08/21/2019 |
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 | 05/31/2018 |
Device Model Number | 92129 |
Device Catalogue Number | 92129 |
Device Lot Number | 136036 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/09/2019 |
Distributor Facility Aware Date | 08/21/2019 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
08/21/2019
|
Initial Date FDA Received | 09/09/2019 |
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 | 69 YR |
|
|