InjuryQAI
REJUVAPEN NXT
Received Apr 27, 2021 · Event occurred Apr 20, 2021
Report MW5101042 · MDR key 11737864
Device
Generic name
Powered Microneedle Device
Manufacturer
Refine Usa, LlcProduct problems
- Output Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
REFINE USA A MEDICAL DEVICE COMPANY IS AWARE THAT THERE IS A MAJOR MALFUNCTION WITH THEIR TIPS. THE MICRO-NEEDLING DEVICE IS NOT TREATING AT PROPER NEEDLE DEPTHS. THERE SHOULD BE A TOTAL RECALL OF THE CARTRIDGES, HOWEVER THE COMPANY IS NOT TAKING ANY PRECAUTION OR COMMUNICATING THE POSSIBILITY OF MALFUNCTION. (B)(6). FDA SAFETY REPORT ID# (B)(4).