Brand Name | ASKU |
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 |
|
MDR Report Key | 9650390 |
MDR Text Key | 177159245 |
Report Number | 6000034-2020-00272 |
Device Sequence Number | 1 |
Product Code |
LXB
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial,Followup |
Report Date |
01/31/2020,01/29/2021 |
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 Model Number | ASKU |
Device Catalogue Number | ASKU |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/31/2020 |
Distributor Facility Aware Date | 01/07/2020 |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 01/31/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/30/2020 |
Supplement Dates Manufacturer Received | 01/29/2021
|
Supplement Dates FDA Received | 02/22/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|