Brand Name | VERMED ECG MONITORING ELECTRODES |
Type of Device | ELECTRODE ELECTROCARDIOGRAPH |
Manufacturer (Section D) |
NISSHA FIS, INC |
1051 perimeter dr |
ste 600 |
schaumburg IL 60173 |
|
MDR Report Key | 7780311 |
MDR Text Key | 117255775 |
Report Number | MW5079121 |
Device Sequence Number | 1 |
Product Code |
DPS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
08/09/2018 |
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 Lot Number | 50117V13 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/13/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 57 YR |
Patient Weight | 98 |
|
|