MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for NUFACE TRINITY DEVICE AND ELE ATTACHMENT manufactured by Carol Cole Company.
[180870142]
I used the nuface trinity device for about 1 month as directed which they said is fda cleared. I got seriously horrific side effects where there is fluid build up inside both eyes, got a subconjunctival hemorrhage in left eye, swelling under both eyes, inflamed nerves throughout face and inside of mouth, headaches, feeling sensitivity to gums and teeth. I have been to my eye dr multiple times and he said he would never recommend this device to anyone as there are too many nerves in face and eyes. It has been 7 weeks since stopped using this device and i am still so inflamed and eyes have not healed. This has been a very scary experience. This device is not safe and is extremely dangerous. And it is for a temporary fix which is not worth the risks involved. This product should be taken off the market.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093223 |
| MDR Report Key | 9744913 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-27 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUFACE TRINITY DEVICE AND ELE ATTACHMENT |
| Generic Name | STIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES |
| Product Code | NFO |
| Date Received | 2020-02-21 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAROL COLE COMPANY |
| Product Code | --- |
| Date Received | 2020-02-21 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |