MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-26 for 3M? RED DOT? SOFT CLOTH MONITORING ELECTRODES N/A 2255-50 manufactured by 3m Health Care.
[137172400]
Information was not provided. Based on the information provided, the reported reaction may be an individual patient sensitivity or potential allergy. End of report.
Patient Sequence No: 1, Text Type: N, H10
[137172401]
A consumer reported four 2255-50 3m? Red dot? Soft cloth monitoring electrodes were applied for cardiac monitoring. The consumer allegedly experienced a bright red raised rash, extreme itching and oozing three days after application of the electrodes. The electrodes and cardiac monitoring were discontinued. The reaction started to spread outside the area where the electrodes were applied. The consumer reportedly consulted a dermatologist and was treated with a topical rx ointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00029 |
| MDR Report Key | 8370845 |
| Report Source | CONSUMER |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-10 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2019-02-26 |
| 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 | 2019-02-26 |
| Model Number | N/A |
| Catalog Number | 2255-50 |
| Lot Number | 2020-11 HH |
| 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 | 2019-02-26 |