OMNILUX MASK
Received Jan 31, 2022 · Event occurred Oct 28, 2021
Report MW5107110 · MDR key 13417947
Device
Generic name
Over-the-counter Powered Light Based Laser For Acne
Manufacturer
Globalmed Technologies Co.Product problems
- Temperature Problem
Patient
48 YR · Female
- Skin Discoloration
- Blurred Vision
- Skin Inflammation/ Irritation
- Skin Discoloration
- Blurred Vision
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
REPORTER USED OMNILUX MASK AND HER FACE WAS LEFT DRY, IRRITATED SKIN WITH DARK PIGMENTATION. REPORTER COMPLAINS THAT SHE SUFFERS WITH BLURRY VISION FROM THE LIGHT THERAPY. "WHILE USING THE MASK IT BECOMES WARM TO TOUCH AND IT SHOULDN'T." SHE HAS USED LIGHT THERAPY IN THE PAST AND NOTICED THE LIGHT BULBS ARE DIFFERENT FROM THE LAST DEVICE. WHILE ON A SOCIAL MEDIA FORUMS ALL OF THE PEOPLE WHO USED THIS DEVICE HAD THE SAME COMPLAINTS OF SKIN INFLAMMATION. REPORTER STATES THAT SHE'S TRIED TO CONTACT THE MANUFACTURER AND RECEIVED A "CANNED RESPONSE" EMAIL. "THIS SEEMS TO BE A SUPPLY CHAIN PROBLEM."