MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for SECRET RF manufactured by Unknown.
[176492390]
Had rf microneedling treatment to cheeks/face using secret rf product applied by (b)(6). I had significant redness followed by extensive peeling, similar to a severe sunburn. I believe the burns were due to too much rf radiation. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092462 |
| MDR Report Key | 9622988 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-21 |
| Date of Event | 2018-06-19 |
| Date Added to Maude | 2020-01-23 |
| 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 | 3 |
| Brand Name | SECRET RF |
| Generic Name | SKIN RESURFACING RF APPLICATOR-SECRET RF |
| Product Code | OUH |
| Date Received | 2020-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |