Type of Device | COCHLEAR BAHA CONNECT SYSTEM |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
mölnlycke, 435 3 3 |
SW 435 33 |
|
MDR Report Key | 18620759 |
MDR Text Key | 334256071 |
Report Number | 6000034-2024-00357 |
Device Sequence Number | 1 |
Product Code |
MAH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/05/2024,02/15/2024 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/01/2024 |
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
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/05/2024 |
Distributor Facility Aware Date | 02/15/2024 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/15/2024 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|