MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-07 for 3M? RED DOT? FOAM MONITORING ELECTRODES N/A 2560 manufactured by 3m Health Care.
[135515078]
Consumer reported the event occurred in (b)(6) 2018. Specific date was not provided. (b)(6) 2018 was used for date of event in this report. Lot number was not provided. Without a lot number, expiration date and manufacture date could not be determined. Full reporter information (email and phone number) was not provided. The consumer reported the event occurred in (b)(6) 2018. There was neither a product sample available for analysis nor a lot number provided for evaluation of any specific manufacturing or release documentation. Although the consumer reported 2560 3m? Red dot? Electrodes were applied, the report also indicated more than one type of electrode (possibly from a different manufacturer) may have been applied to this consumer. No information was available regarding other electrodes applied to the consumer. Based on the information provided, the reported reaction may be an individual sensitivity / allergic contact dermatitis. End of report.
Patient Sequence No: 1, Text Type: N, H10
[135515079]
A consumer reportedly experienced an allergic reaction described as itching, redness, swelling, blisters, folliculitis and skin tears following use of 2560 3m? Red dot? Foam monitoring electrodes. The consumer also reported experiencing general malaise, fatigue and headaches. Dermatology and allergy specialists were consulted. The reaction was treated with and unspecified type of allergy medication and cortisone cream. The consumer reported the skin was no longer open and minimal scaring occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00024 |
| MDR Report Key | 8316340 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2019-01-17 |
| Date Added to Maude | 2019-02-07 |
| 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? FOAM MONITORING ELECTRODES |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-02-07 |
| Model Number | N/A |
| Catalog Number | 2560 |
| 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 | 2019-02-07 |