GLO SCIENCE'S SO BRILLIANT WHITENING KIT
Received Jan 9, 2025 · Event occurred Nov 11, 2024
Report MW5164538 · MDR key 21125286
Device
Generic name
Heat Source For Bleaching Teeth
Manufacturer
Glo Science, Inc.Patient
33 YR · Female
- Hypersensitivity/Allergic reaction
- Peeling
- Burning Sensation
- Caustic/Chemical Burns
- Swelling/ Edema
- Hypersensitivity/Allergic reaction
- Peeling
- Burning Sensation
- Caustic/Chemical Burns
- Swelling/ Edema
Narrative
Description of Event or Problem
ON (B)(6) 2024, I HAD A TEETH WHITENING PROCEDURE COMPLETED AT MY DENTIST. THE PRODUCT USED WITH GLO SCIENCE'S "SO BRILLIANT" TEETH WHITENING KIT. I WAS GIVEN THE PROPER DOCUMENTATION, DISCLAIMERS, WAIVERS, AND WALKED THROUGH THE PROCESS OF WHAT WOULD HAPPEN. HOWEVER, NONE OF THESE DISCLOSED THAT I COULD HAVE AN ALLERGIC REACTION OR CHEMICAL BURN. THIS IS WHAT OCCURED. SOMEWHERE BETWEEN THE 1-3 TRAYS, I STARTED EXPERIENCING EXTREME SENSITIVITY, TO WHICH I WAS TOLD WAS NORMAL. THE WHITENING AGENT SEEPED INTO MY GUMS AND BY THE END OF TRAY 3 WHEN I ASKED TO STOP, THE DENTAL ASSISTANT AND I BECAME AWARE THAT MY LIPS HAD SWOLLEN 2X THE SIZE THEY SHOULD HAVE BEEN. AFTER BEING ADVISED TO KEEP THE DENTIST INFORMED AND UPDATED, AND THAT THEY COULD WRITE ME A PRESCRIPTION FOR A STEROID TO CALM THE REACTION, I TOOK BENADRYL AT THE OFFICE AND MY HUSBAND PICKED ME UP AND DROVE ME HOME. THE BENADRYL SEEMED TO HELP AND SOOTHE THE SYMPTOMS OF TINGLING, SWELLING, AND OVERALL HEAT TO THE AREA. ONCE HOME, THE REACTION SEEMED TO WORSEN AGAIN THOUGH WITHIN 30 MINUTES, TO WHICH WE WENT TO THE HOSPITAL. AT THIS HOSPITAL, MY LIPS BECAME MORE ENLARGED (ABOUT 3X THE SIZE THEY NORMALLY WERE.) AFTER GIVEN 60 MG OF PREDNISONE, THE REACTION SEEMED TO SUBSIDE AND I WAS DISCHARGED. WITHIN THE NEXT 3-4 DAYS, I EXPERIENCED SKIN PEELING AND MY LIPS RETURNED TO NORMAL SIZE WITHIN 48 HOURS. GLO SCIENCE (HTTPS:/ /GLOSCIENCE.COM.