MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-21 for NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES manufactured by Carol Cole Company.
[5663409]
This is (b)(6), a customer who purchased nuface microcurrent facial lifting and toning devices several weeks ago. After using this device three times following the user's instruction, i have had really severe side effects: my face skin became dry and red, then started to peel off and left dark red spot on my face. I contacted customer service from nuface and got the resolution on refund the purchase. However, they are not responsible for the medication service and salary loss for me at this moment. As the nuface device was authorized by fda, i was wondering whether you could help to reevaluate this device. I don't want to see other people suffering side effects that i have been through. Please let me know if you have any questions or need any info. I can send you the proof of my purchase and the side effect pictures (i have pictures before and after using the device). Thank you very much for your time and help. Dates of use: (b)(6) 2015; diagnosis or reason for use: wanted to decrease the wrinkle on the face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042237 |
| MDR Report Key | 4728007 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-04-21 |
| Date Added to Maude | 2015-04-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES |
| Generic Name | FACIAL LIFE AND TONING |
| Product Code | NFO |
| Date Received | 2015-04-21 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAROL COLE COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2015-04-21 |