MAUDE Adverse Event Report: EVERBRAND INC EVERSMILE WHITENING FOAM; WHITENING SOLUTION

Model Number RMS-0007

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/20/2021

Event Type  Injury  

Event Description

As reported by the patient - "patient has a rare allergy to palm oil (aka citric acid) which is a common ingredient in many products.She had been experiencing mild reactions to the whitening foam so far, but on (b)(6) 2021 she accidentally used more foam than usual.Less than a minute after putting on aligners, she began having an increasingly severe allergic reaction.She tried to wait it out, but it lasted for 6 hours and she eventually went to a hospital and has been staying there since.Patient had not eaten anything yet that day, which rules out other potential causes.She had recently started a new medication which she didn't realize contained palm oil, which may have contributed to the reaction in combination with the increased amount of whitening foam applied.

• Brand Name: EVERSMILE WHITENING FOAM
• Type of Device: WHITENING SOLUTION
• Manufacturer (Section D): EVERBRAND INC; 401 n. oak street; inglewood CA 90302
• MDR Report Key: 12751291
• MDR Text Key: 281917958
• Report Number: 3017264291-2021-00001
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: RMS-0007
• Device Catalogue Number: CCBWF25M1PE0001
• Device Lot Number: 21021601X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female