MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. RETAINER BRITE® CLEANING TABLETS 120CT CASE; CLEANSER, DENTURE, OVER THE COUNTER

Catalog Number RB120CASE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Discomfort (2330)

Event Date 02/01/2023

Event Type  Injury  

Event Description

In this event, it is reported that patient experienced an allergic reaction a few weeks after starting use of retainer brite cleaning tab 120ct - persulfate-based retainer/denture cleaner.Patient experienced jaw pain, gum pain and burning sensation in their throat/esophagus.Patient was tested for covid, flu, rsv and strep throat - all negative.Patient was placed on antibiotic.

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Manufacturer Narrative

Product not received.Lot # was not provided.Customer purchased the retainer brite from amazon and discarded the box.The receipt from amazon does not contain the lot #, however it does show that the customer purchased retainer brite.After using retainer brite for about 2 weeks, customer started experiencing jaw pain, red and inflamed lips and burning in the esophagus.Customer tested negative for covid, flu, rsv and strep throat.Customer has been put on an antibiotic and discontinued use of retainer brite.Allergic reactions to persulfates, which is in retainer brite, are known and reported.In the warnings section of the retainer brite box it states ¿contains persulfates which are a known allergen¿ and lists allergic reactions in the adverse reactions section of the packaging and ifu.(nrg) conclusion code - event caused by patient conditions/factors.

• Brand Name: RETAINER BRITE® CLEANING TABLETS 120CT CASE
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16408516
• MDR Text Key: 309881515
• Report Number: 1036212-2023-00002
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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?: No
• Device Catalogue Number: RB120CASE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/15/2023
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1