Brand Name | 3M RED DOT (TM) MONITORING ELECTRODE |
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, manitoba R6M 1 Z9 |
CA
R6M 1Z9
|
|
Manufacturer Contact |
linda
johnsen
|
3m center, building 275-5w-06 |
2510 conway ave |
st. paul, MN 55144
|
6517374376
|
|
MDR Report Key | 5362288 |
MDR Text Key | 35727525 |
Report Number | 2110898-2016-00001 |
Device Sequence Number | 1 |
Product Code |
DRX
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | PREAMENDMENT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/14/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | N/A |
Device Catalogue Number | 2239 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/14/2015 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 29 YR |
|
|