Brand Name | EASY TOUCH |
Type of Device | BLOOD PRESSURE MONITOR |
Manufacturer (Section D) |
MHC MEDICAL PRODUCTS, LLC |
11930 kemper springs drive |
cincinnati OH 45240 |
|
MDR Report Key | 7471398 |
MDR Text Key | 107355957 |
Report Number | 3005798905-2018-00483 |
Device Sequence Number | 1 |
Product Code |
DXN
|
Combination Product (y/n) | N |
PMA/PMN Number | K091434 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Remedial Action |
Replace |
Type of Report
| Initial,Followup |
Report Date |
04/28/2018 |
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 | N/A |
Device Catalogue Number | 860213 |
Device Lot Number | NOT PROVIDED |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/09/2018 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/30/2018 |
Initial Date FDA Received | 04/29/2018 |
Supplement Dates Manufacturer Received | 03/30/2018
|
Supplement Dates FDA Received | 09/19/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|