Brand Name | C6 MCOT PPM |
Type of Device | C6 MCOT PPM |
Manufacturer (Section D) |
BRAEMAR MANUFACTURING, LLC |
1285 corporate center drive |
suite 150 |
eagan MN 55121 |
|
Manufacturer (Section G) |
BRAEMAR MANUFACTURING, LLC |
1285 corporate center drive |
suite 150 |
eagan MN 55121 |
|
Manufacturer Contact |
beverly
okoh
|
1285 corporate center drive |
suite 150 |
eagan, MN 55121
|
|
MDR Report Key | 18832869 |
MDR Text Key | 336853071 |
Report Number | 2133409-2024-00015 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081444 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/16/2024 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 02-01606 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/04/2024 |
Supplement Dates Manufacturer Received | 04/10/2024
|
Supplement Dates FDA Received | 04/16/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/15/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 77 YR |
Patient Sex | Male |