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

Catalog Number RB-368C

Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); No Code Available (3191)

Event Type  Injury  

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 is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a customer ordered retainer brite from (b)(6) and upon opening the product, reported a "bleachy" smell.The customer used the product correctly and reported his mouth was red and it "felt like a burn" after use.The customer did not relate the reaction to the product.The next day, the customer used the product again and had the same reaction.

Manufacturer Narrative

This investigation has been completed by the vendor.The vendor found no issues during the review of the suspect batch or retains.According to the vendor, "our tablets routinely undergo rigorous testing for physical, analytical, and sensory properties, and consistently meet and/or exceed nbe standards.".

• Brand Name: RETAINER BRITE CLEANING TABLETS
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• MDR Report Key: 7891274
• MDR Text Key: 120825963
• Report Number: 1036212-2018-00004
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RB-368C
• Device Lot Number: PN 4494GT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR