Brand Name | UNIT, C6M, A10E |
Type of Device | UNIT, C6M, A10E U |
Manufacturer (Section D) |
BRAEMAR MANUFACTURING, LLC |
1285 corporate center drive |
suite 150 |
eagan MN 55121 |
|
Manufacturer (Section G) |
BRAEMAR MANUFACTURING, LLC |
1285 corporate center dr |
suite 150 |
eagan MN 56121 |
|
Manufacturer Contact |
beverly
okoh
|
1285 corporate center drive |
suite 150 |
eagan, MN 55121
|
6124263781
|
|
MDR Report Key | 15992427 |
MDR Text Key | 305580472 |
Report Number | 2133409-2022-00016 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | B146C6M70 |
UDI-Public | B146C6M70 |
Combination Product (y/n) | N |
PMA/PMN Number | K171410 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/15/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 02-01804 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/16/2022
|
Initial Date FDA Received | 12/15/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|