MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for THE DERMINATOR manufactured by Vaughter Wellness (owndoc.com).
[98593360]
(b)(6) sells dermaneedling devices called the derminator at (b)(6). These devices are sold as safe and (b)(6) falsely reports that no one has been harmed by her device. I have found others on her forums who had the same bad reaction as me. So she lies about this. I used her device in (b)(6) and got permanent holes and bumps on my forehead, and an increase in acne. I do not have the item. I am sorry i did not get that information. But these items are sold at (b)(6). Please stop them from being imported into the us. They destroy skin. Permanent damage to skin, does require help to fix the damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074884 |
| MDR Report Key | 7221457 |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-15 |
| Date of Event | 2017-05-19 |
| Date Added to Maude | 2018-01-26 |
| 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 | THE DERMINATOR |
| Generic Name | THE DERMINATOR |
| Product Code | GFE |
| Date Received | 2018-01-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VAUGHTER WELLNESS (OWNDOC.COM) |
| Manufacturer Address | 35A ASTBURY RD. OFFICE Q LONDON SE152NL UK SE15 2NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-25 |