MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for NUFACE MINI FACIAL TONING DEVICE manufactured by Carol Cole Company.
[50929176]
After using nuface mini facial toning device for approx 4 weeks my tooth/crown became loose and fell out of my mouth. I have been in contact with nuface and advised them of my experience. I can't imagine i am the only woman with crowns in her mouth and would like to know if this micro current can vibrate cracks in the material that seats crowns. I am reluctant to continue use of this device until i know this micro current is safe for use by people with crowns on their teeth. Route: applied to a surface, usually the skin. Dates of use: (b)(6) 2016. Diagnosis or reason for use: cosmetic/facial toning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063755 |
| MDR Report Key | 5836223 |
| Date Received | 2016-07-27 |
| Date of Report | 2016-07-27 |
| Date of Event | 2016-06-22 |
| Date Added to Maude | 2016-08-01 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUFACE MINI FACIAL TONING DEVICE |
| Generic Name | SKIN TONER |
| Product Code | NFO |
| Date Received | 2016-07-27 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAROL COLE COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2016-07-27 |