Brand Name | RHYTHMLINK EEG LEADS |
Type of Device | ELECTRODE, CUTANEOUS |
Manufacturer (Section D) |
RHYTHMLINK INTERNATIONAL, LLC. |
|
|
MDR Report Key | 15401762 |
MDR Text Key | 299770562 |
Report Number | MW5111966 |
Device Sequence Number | 1 |
Product Code |
GXY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
09/07/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/09/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 12 YR |
Patient Sex | Female |
Patient Weight | 68 KG |
Patient Race | White |
|
|