MalfunctionQAI
DR PEN USA MICRONEEDLING DEVICE
Received Jul 16, 2021 · Event occurred Jul 14, 2021
Report MW5102615 · MDR key 12188910
Device
Generic name
Powered Microneedle Device
Manufacturer
Guangzhou Ekai Electronic Technology Co.,ltd.Model number
A8, A6, A6S, A7Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
INFECTION; DR PEN SELLS ONLINE (B)(6) BUT ALSO ON(B)(6) AS A MICRONEEDLING DEVICE BUT NO FDA APPROVAL, YET STATES THAT IT CAN HELP WITH WRINKLES, ANTI AGING, HAIR, THINNING LAX SKIN, STRETCH MARKS, ACNE MARKS. FDA SAFETY REPORT ID # (B)(4).