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 | 11033365 |
MDR Text Key | 222270775 |
Report Number | 6000034-2020-03477 |
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 |
01/28/2021,01/05/2021 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 12/17/2020 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
LAY USER/PATIENT
|
Device MODEL Number | ASKU |
Was Device Available For Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/28/2021 |
Distributor Facility Aware Date | 01/05/2021 |
Event Location |
No Information
|
Date Report TO Manufacturer | 10/28/2020 |
Was Device Evaluated By Manufacturer? |
No Answer Provided
|
Is The Device Single Use? |
No Answer Provided
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
|
Patient TREATMENT DATA |
Date Received: 12/17/2020 Patient Sequence Number: 1 |
|
|