MAUDE Adverse Event Report: GLO SCIENCE, INC. SO BRILLIANT WHITENING KIT; TEETH WIGHTENING DEVICE KIT

Model Number	7581042
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Peeling (1999); Burning Sensation (2146); Caustic/Chemical Burns (2549); Swelling/ Edema (4577)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information via email to our customer service from the patient: "after a routine teeth cleaning at my dentist on (b)(6) 2024, i was taken to next room for whitening.I carefully read through and signed the paperwork.The dental assistant further notified me that if sensitivity occurs, they would either put vitamin e balm on it or stop treatment.I reminded her of my latex and gluten allergies.It was noted by the attendant that we were okay to proceed.Before the first tray, i applied the vitamin e all over my lips due to the sensitivity.I offered to just use my vaseline, but the assistant said to thaw the vitamin e balm since it came with the kit anyways.In the 1st tray / round, i had sensitivity and bubbling sensation on bottom left first molar.Towards the end of the 8 min, i had a sharp zing that i contracted from laying down and the assistant took out the materials.And stopped the treatment.In between, the dental assistant applied additional cover care to the gum area and this seemingly fixed that issue.I also asked the assistant to not put whitening care on that area of the bottom left molars since my smile covers those teeth anyways.Assistant suctioned additional fluid from inner lip areas.In the 2nd tray / round, i had bubbling sensation on my inner bottom lip.Because the assistant was out of room, i reached over and put on the vitamin e care on my bottom lip and held my lip away from the light to stop the sensation.I also had a few small zings on the bottom left first molar, but they were small and not very intense or painful.She came back in and suctioned the inner lip area after this part was done.In the 3rd tray / round, i had essentially no problem.However, i told the assistant, who was now in the room, that it felt like i was drooling in the affected area of the bottom lip.She said i was not.No other pain was present and i finished the 8 min.When i started the 4th round, i started with no problem, but some slight sensitivity around the gums in general.3 minutes into that round, i had sharp lasting pain in the bottom right so treatment stopped as i asked to be done.When the equipment was taken out of my mouth, i immediately noticed by feeling/sensation that my bottom lip was swollen - at least double in size.The assistant rinsed my mouth well.And that is when, by moving my tongue around, i realized my lips were extremely swollen and i notified the assistant.When the assistant looked at it, and told me that it would be okay and she would get the dentist.When the dentist came in, i asked for a cold compress or ice.He discussed that i was potentially having a reaction to the materials and they would look into it further.With a nod from my dentist, i then took 2, 25 mg of benadryl from my purse in the office since they did not have any.I was given a small ice compress provided.They noted it could be an allergic reaction to one of the chemicals but no known chemicals for any allergies i mentioned such as latex, lanolin (wool products.) the dental assistant asked if i had any cosmetic surgery or lip filler, which i confirmed i did not have anything else prior.Also confirmed that i have previously had no issue with at home whitening products.At this point, i called my fiance to pick me up.My teeth appeared whitened and looked well.The dentist did one last look and examined my mouth to ensure no other impact.I noted that it looked like my lip stopped increasing in size at the time, likely from the benadryl.They said to call the dentist who provided his personal number at the time to call if there was any further issue swelling or sensitivity.After going home and putting ice on it, it seemed okay.But after about 30 minutes, i noticed it was getting bigger and more red.I ended up going to the hospital.Once at the hospital, the attendant nurse told me to stop icing it.Put on lavender oil topically to my bottom lip to help with swelling and neutralizing reaction.Lip felt swollen and chapped.Within the hour, it was 2-3x normal size with a lump in the bottom left where the drooling sensation was felt.After receiving 60 mg of prednisone at the hospital, it appeared to stop swelling.The heat immediately reduced and the tingling sensation dissipated.Then i was discharged.Within the next 3-4 days, i experienced skin peeling and my lips returned to normal size within 48 hours.No other issues have occured.
Event or Problem Description
From medwatch report mw5164538: 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.

• Brand Name: SO BRILLIANT WHITENING KIT
• Common Device Name: TEETH WIGHTENING DEVICE KIT
• Manufacturer (Section D): GLO SCIENCE, INC.; 10 w. 37th street; new york NY 10018
• Manufacturer (Section G): GLO SCIENCE, INC.; 10 w. 37th street; new york NY 10018
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 21350502
• Report Number: 3008475975-2025-00001
• Device Sequence Number: 8212666
• Product Code: EEG
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7581042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELDERBERRY AND ZINC SUPPLEMENTS; PRENATAL VITAMINS
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian