HIGHERDOSE

Additional Manufacturer Narrative

THE PRODUCT BATCH INVOLVED IN THE ALLERGIC EVENT IS LOT 10765AKY, WITH SN (B)(6). THE CAUSE OF THE ALLERGY IS STILL UNDER INVESTIGATION. THE PRELIMINARY ASSESSMENT SUGGESTS IT MAY BE DUE TO PHOTOSENSITIVITY OR A SILICONE ALLERGY. THE ESTIMATED COMPLETION TIME OF THE INVESTIGATION IS AROUND THE END OF AUGUST 2026.

Description of Event or Problem

PLEASE FIND BELOW A DESCRIPTION OF THE EVENT OR CONCERN AS REPORTED BY THE CUSTOMER. USED HIGHER DOSE RED LIGHT MASK AT HOME ON TWO SEPARATE OCCASIONS. BOTH TIMES AFTER ABOUT 4 HOURS DEVELOPED A PAINFUL, ITCHING, BURNING BRIGHT RED RASH ON CHEEKS AND ACROSS EYEBROWS. REQUIRED HIGHDOSE CETIRIZINE, FAMOTIDINE, TOPICAL STEROIDS, ORAL STEROIDS. RASH BECAME SAND PAPERY AND THEN BUMPY LIKE ECZEMA. TOOK ABOUT 2 WEEKS TO FULLY RESOLVE. BOTH TIMES REQUIRED MEDICAL ATTENTION.