Brand Name | UNIT, EPATCH 2.0, BTH/UNIVERSAL ELECTRODE-PATCH |
Type of Device | UNIT, EPATCH 2.0, BTH/UNIVERSAL ELECTRODE-PATCH |
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 |
|
MDR Report Key | 16809191 |
MDR Text Key | 313945224 |
Report Number | 2133409-2023-00017 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | B146EP2010 |
UDI-Public | B146EP2010 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K171410 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/12/2023 |
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 | 02-01575 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/04/2023
|
Initial Date FDA Received | 04/25/2023 |
Supplement Dates Manufacturer Received | 04/04/2023
|
Supplement Dates FDA Received | 05/12/2023
|
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 20 YR |
Patient Sex | Female |
|
|