Brand Name | BIM400 IMPLANT MAGNET |
Type of Device | COCHLEAR BAHA ATTRACT SYSTEM |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
mölnlycke, 435 3 3 |
SW 435 33 |
|
MDR Report Key | 17779202 |
MDR Text Key | 323785126 |
Report Number | 6000034-2023-03016 |
Device Sequence Number | 1 |
Product Code |
LXB
|
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 |
10/26/2023,10/09/2023 |
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 | 93550 |
Device Catalogue Number | 93550 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/26/2023 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/26/2023 |
Distributor Facility Aware Date | 10/09/2023 |
Date Report to Manufacturer | 10/09/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/20/2023 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 10/26/2023
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 65 YR |
Patient Sex | Male |
|
|