Brand Name | ECG ELECTRODES RADIOLUCENT NEOLEAD |
Type of Device | ELECTRODE, ELECTROCARDIOGRAPH |
Manufacturer (Section D) |
|
MDR Report Key | 15163442 |
MDR Text Key | 297322325 |
Report Number | MW5111256 |
Device Sequence Number | 1 |
Product Code |
DRX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
08/01/2022 |
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 |
Health Professional
|
Device Model Number | N305 |
Device Lot Number | 2022-3023 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/03/2022 |
Patient Sequence Number | 1 |
Patient Age | 8 DA |
Patient Sex | Female |
|
|