MAUDE Adverse Event Report: DENTSPLY LLC. RETAINER BRITE; CLEANSER, DENTURE, OVER THE COUNTER

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Burning Sensation (2146)

Event Date 02/01/2023

Event Type  Injury  

Event Description

I used a persulfate based retainer cleaner for about 2 weeks to soak my retainer.I started noticing some jaw pain (b)(6) 2023 and by the next day, the pain significantly worsened and spread to my gums, which were red and inflamed.I also had burning in my esophagus.I do not have any dental problems or gum issues or medical problems, and tested negative for covid, flu, rsv and strep throat.I have been put on an antibiotic and will discontinue the use.

• Brand Name: RETAINER BRITE
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): DENTSPLY LLC.
• MDR Report Key: 16305298
• MDR Text Key: 308963531
• Report Number: MW5114699
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/01/2023

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Patient Sequence Number: 1
• Treatment: COLLAGEN; FLONASE; MULTIVITAMIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Hispanic
• Patient Race: White