MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2019-05-15 for 3M? RED DOT? SOFT CLOTH MONITORING ELECTRODES N/A 2660-5 manufactured by 3m Health Care.
[145124083]
The consumer did not have product catalog or lot numbers. 3m contacted the distributor who provided the product information. No samples or photos have been received for this report. The consumer would not provide consent to contact her health care provider for information related to this report. A review of the quality documentation related to the electrode product lot did not reveal any quality issues with the product.
Patient Sequence No: 1, Text Type: N, H10
[145124084]
A consumer reported 3m red dot electrodes and a bodyguardian? Verite heart monitor were being used for a 30-day cardiac monitoring test. The consumer reportedly wore the electrodes for 13 days without issue. On the 14 day, she reportedly started to experience a "tingling sensation" under the electrode stubs and the following day, the "tingling sensation" became intense. The consumer reported the monitor and lead wires were heating up. The consumer stated she was seen in an urgent care and diagnosed with "2nd degree electrical burns on four chest sites due to a faulty electrode monitor. " she was reportedly given a prescription for silvadene cream and received a tetanus (tdap) shot. She was instructed to follow-up the same day at a walk-in clinic to evaluate the skin burns and was seen by a dermatologist. She was given an rx for santyl ointment, instructed to take ibuprofen. She was also instructed to follow-up with her cardiologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00073 |
| MDR Report Key | 8612001 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2018-12-16 |
| Date Added to Maude | 2019-05-15 |
| 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 |
| 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? SOFT CLOTH MONITORING ELECTRODES |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-05-15 |
| Model Number | N/A |
| Catalog Number | 2660-5 |
| Lot Number | 2020 -12 EW |
| Operator | LAY USER/PATIENT |
| 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 | 2019-05-15 |