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

Catalog Number	RB-36
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional 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 complaint form was submitted to us as a voluntary report from the fda (mw5078826).The fda has the wrong code listed for retainer brite on this complaint form, as code dyj should be code eft for the class 1 us medical device code for retainer brite.Review of the anonymous complaint, it appears that this customer was overusing this product.The dfu for retainer brite calls for a retainer to be soaked in this product for 10-15 minutes, one time per day.The details mention that the product was used for soaking overnight, and possibly multiple times per day, for a couple of years.No lot information was retrieved in order for us to conduct a review of the batch record or retain samples for this complaint.We did review our complaint trending and have confirmed no other serious adverse reactions have been received for this product.The product label does contain a persulfate allergy warning and we always strongly recommend consumers follow the instructions on the label carefully.The instructions state: "do not put tablets or cleaning solution in mouth" and "rinse appliance and hands thoroughly with running water" after soaking in the solution.
Event or Problem Description
"for two years i lost the ability to digest food well.About every other b.M.Was the runs.I lost significant weight and had severe dehydration.The problem resolved after ending invisalign retainer and retainer brite cleaner.I switched to an acrylic and metal retainer and baking soda and vinegar cleaning.My digestion improved except for a severe reaction to dairy.During this illness, i developed arthritis.I asked my dentist what the retainer was made of.He said they are made in (b)(4) and could not tell me because it was proprietary.I paid (b)(6) for core and testing in addition to what my insurance paid.The only relief was i.V.S.The drs and specialists had no explanation.I tried the retainer on my own initiative based on the fact, i broke out in facial sweat when i ate food.An mri showed hip arthritis that explained the pain that started during this illness.Invisalign - dental retainer; retainer brite - retainer cleaner; 1 tab/night, 1/day, 1 tablet in water with retainer overnight.Date the person first started taking or using the product: (b)(6) 2015; date the person stopped taking or using the product: (b)(6) 2017."did the problem stop after the person reduced the dose or stopped taking or using the product: yes; did the problem return if the person started taking or using the product again: didn't restart.".

• Brand Name: RETAINER BRITE
• Common Device Name: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• MDR Report Key: 7870529
• Report Number: 1036212-2018-00003
• Device Sequence Number: 12191148
• Product Code: EFT
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

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: Lay User/Patient
• Device Catalogue Number: RB-36
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other