Brand Name | COCHLEAR¿ VISTAFIX® VXI300 IMPLANT 4MM |
Type of Device | COCHLEAR BAHA VISTAFIX 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 | 8778885 |
MDR Text Key | 150677331 |
Report Number | 6000034-2019-01173 |
Device Sequence Number | 1 |
Product Code |
FZE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K945154 |
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 |
07/11/2019,06/26/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/10/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 93101 |
Device Catalogue Number | 93101 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/11/2019 |
Event Location |
Home
|
Date Manufacturer Received | 06/26/2019 |
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) |
Required Intervention;
|