MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-28 for BEUTICONTROL OXYGENZONE manufactured by Beauticontrol.
[19585189]
My mother told me about a product called oxygenzone from a company called beauticontrol. The product claims it produces ozone (o3) for health benefits. The problem with this is that ozone is toxic to pretty much all biological life including people. My mother claims her skin gets red after using the product, which is a sign of irritation, and i'm worried this thing is damaging her and others. It's a skin care device claiming all manner of nonsense while simultaneously exposing people to ozone, which is not safe. The premise is that you rub your skin with this wand of sorts for health benefits, but from what i can tell all it does is irritate the skin. Because it's harmful. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036423 |
| MDR Report Key | 3846027 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-16 |
| Date of Event | 2014-05-11 |
| Date Added to Maude | 2014-06-05 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | BEUTICONTROL |
| Generic Name | BEUTICONTROL |
| Product Code | NZF |
| Date Received | 2014-05-28 |
| Model Number | OXYGENZONE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEAUTICONTROL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-28 |