InjuryONF
LUMECCA BY INMODE IPL
Received Jul 21, 2022 · Event occurred Jun 30, 2022
Report MW5111057 · MDR key 15085774
Device
Generic name
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
Manufacturer
Invasix / Inmode Ltd.Model number
AG606991AProduct problems
- Unexpected Therapeutic Results
Patient
57 YR · Female
- Skin Discoloration
- Skin Discoloration
Narrative
Description of Event or Problem
INMODE EQUIPMENT USED FOR IPL TREATMENT TO IMPROVE SKIN CLARITY ON CHEST, ARMS AND BACK AREA RESULTING IN STRIPING. START: (B)(6) 2022; STOP: (B)(6) 2022. THERAPY IS STILL ONGOING. DIAGNOSIS FOR USE: Z41.1 (COSMETIC). FDA SAFETY REPORT ID# (B)(4).