MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-01 for 3M? RED DOT? MONITORING ELECTRODES N/A 2670-5 manufactured by 3m Health Care.
[134769613]
Lot number was not provided. Without a lot number, expiration date and manufacture date cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[134769614]
A hospital imaging manager alleged three 2670-5 3m? Red dot? Soft cloth monitoring electrodes were applied to a patient in the emergency room. A few hours following application of the electrodes, the patient was transferred to the imaging area for an mri procedure. The patient did not have cardiac monitoring during the mri, but the electrodes were reportedly left on his skin. The patient stated he felt pain under the electrodes during the mri but did not say anything until the test was completed. The patient allegedly experienced circular burns under the electrode stubs. He was seen by a physician in the er and was treated with rx silvadene cream.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00019 |
| MDR Report Key | 8297707 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-01 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-12 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M CANADA COMPANY |
| Manufacturer Street | 400 ROUTE 100 |
| Manufacturer City | MORDEN, R6M 1Z9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | R6M 1Z9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? RED DOT? MONITORING ELECTRODES |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-02-01 |
| Model Number | N/A |
| Catalog Number | 2670-5 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-01 |