MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for NUFACE MINI NUFACE MINI FACIAL TONING DEVICE manufactured by Carol Cole Company.
[140546521]
I began using the nuface mini product in (b)(6). I have a blood pressure monitor. I noticed after using the device when i took my readings that the irregular heartbeat icon came on. I? Ve taken my bp for years and its never happened. It continued to happen while i was using the nuface mini and as soon as i quit using it regular readings quit happening. While i was using, i could feel the current and in my chest it felt like i could feel a current sensation which was odd. I didn? T think much of it at first until the blood pressure monitor alerted me and then i became very aware of the strange feeling in my chest when i used the nuface mini. Purchased from (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085403 |
| MDR Report Key | 8470387 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-02-04 |
| Date Added to Maude | 2019-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUFACE MINI |
| Generic Name | STIMULATOR, TRANCUTANEOUS ELECTRICAL |
| Product Code | NFO |
| Date Received | 2019-03-29 |
| Model Number | NUFACE MINI FACIAL TONING DEVICE |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAROL COLE COMPANY |
| Brand Name | NUFACE MINI |
| Generic Name | STIMULATOR, TRANCUTANEOUS ELECTRICAL |
| Product Code | GZJ |
| Date Received | 2019-03-29 |
| Model Number | NUFACE MINI FACIAL TONING DEVICE |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAROL COLE COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-29 |