Brand Name | BIM400 IMPLANT MAGNET |
Type of Device | COCHLEAR BAHA ATTRACT 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 |
bianca
pries
|
1 university avenue |
macqaurie university, nsw 2109
|
AS
2109
|
|
MDR Report Key | 7478762 |
MDR Text Key | 107068076 |
Report Number | 6000034-2018-00960 |
Device Sequence Number | 1 |
Product Code |
LXB
|
UDI-Device Identifier | 09321502025294 |
UDI-Public | (01)09321502025294(10)90453(17)02282019 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131240 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/16/2018 |
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 | 02/28/2019 |
Device Model Number | 93550 |
Device Catalogue Number | 93550 |
Device Lot Number | 90453 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/02/2018 |
Supplement Dates Manufacturer Received | 04/16/2018
|
Supplement Dates FDA Received | 05/09/2018
|
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 | 53 YR |