Brand Name | 3M¿ RED DOT¿ MONITORING ELECTRODES |
Type of Device | ECG ELECTRODE |
Manufacturer (Section D) |
3M HEALTH CARE |
2510 conway ave |
st. paul MN 55144 |
|
Manufacturer (Section G) |
3M CANADA COMPANY |
400 route 100 |
|
morden, R6M 1 Z9 |
CA
R6M 1Z9
|
|
Manufacturer Contact |
dianne
gibbs
|
3m center, building 275-5w-06 |
st. paul, MN 55144
|
6517379117
|
|
MDR Report Key | 8160628 |
MDR Text Key | 130222189 |
Report Number | 2110898-2018-00112 |
Device Sequence Number | 1 |
Product Code |
DRX
|
UDI-Device Identifier | 10707387499966 |
UDI-Public | 10707387499966 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/13/2018 |
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 |
Health Professional
|
Device Expiration Date | 10/23/2020 |
Device Model Number | N/A |
Device Catalogue Number | 2670-5 |
Device Lot Number | 2020 10 FH |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/16/2018 |
Initial Date FDA Received | 12/13/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/24/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | LEAD WIRES |
Patient Outcome(s) |
Death;
|
Patient Age | 80 YR |