MEDIDERMA PRO RF
Received Jul 19, 2017 · Event occurred Jun 26, 2017
Report MW5071125 · MDR key 6732234
Device
Generic name
Skin Resurfacting Rf Applicator
Manufacturer
MedicreationsProduct problems
- Inadequate or Insufficient Training
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
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."