Brand Name | BIM400 IMPLANT MAGNET |
Type of Device | COCHLEAR BAHA ATTRACT SYSTEM |
Manufacturer (Section D) |
COCHLEAR BONE ANCHORED SOLUTIONS AB |
konstruktionsvägen 14 |
po box 82 |
mölnlycke, 43533 |
SW 43533 |
|
MDR Report Key | 11847166 |
MDR Text Key | 251357612 |
Report Number | 6000034-2021-01391 |
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,Followup |
Report Date |
11/12/2021,10/19/2021 |
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 | 93550 |
Device Catalogue Number | 93550 |
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 | 11/12/2021 |
Distributor Facility Aware Date | 10/19/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/12/2021 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/19/2021 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 07/08/2021 11/11/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 41 YR |
Patient Sex | Female |
|
|