MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-21 for PERFECTIO PLUS manufactured by Zero Gravity Skin.
[65953162]
Perfectio plus is supposed to be used 7 min per area, 3 times a week to correct wrinkles and lift skin. After first time, 2 second exposure, my skin crumbled. Now, two weeks later, i have brown lines and damaged skin. Infrared light of this device by zero skin gravity is advertised for any skin area, including under eye, with no adverse effects. This is dangerous and not true! The company, zero gravity skin, had refused to look into it. I also learned that the product was approved by fda based on an alleged sample of 35. I feel wronged by the process, please at least help get me my money back!
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067486 |
| MDR Report Key | 6279449 |
| Date Received | 2017-01-21 |
| Date of Report | 2017-01-21 |
| Date of Event | 2017-01-10 |
| Date Added to Maude | 2017-01-26 |
| 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 | PERFECTIO PLUS |
| Generic Name | PERFECTIO PLUS |
| Product Code | OHS |
| Date Received | 2017-01-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZERO GRAVITY SKIN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-01-21 |