MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for MEDIDERMA PRO RF manufactured by Medicreations.
[80803409]
Did a product demonstration with a new device called mediderma pro rf by a company called (b)(4). The rep did not have much knowledge about the product, had staff treat each other without much guidance. Staff had markings on their face for at least 2 weeks. Found out device was not fda cleared yet the rep is actively promoting, taking orders and demonstrating the device without proper clearances. "how was it taken or used: subcutaneous. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071125 |
| MDR Report Key | 6732234 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-26 |
| Date Added to Maude | 2017-07-21 |
| 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 |
| 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 | MEDIDERMA PRO RF |
| Generic Name | SKIN RESURFACTING RF APPLICATOR |
| Product Code | OUH |
| Date Received | 2017-07-19 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICREATIONS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-19 |