MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. RETAINER BRITE® CLEANING TABLETS-96 CT-CASE; CLEANSER, DENTURE, OVER THE COUNTER

Catalog Number RB-92-CASE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

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 has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that retainer brite cleaning tablets - 96 ct caused an allergic reaction in patient.This reaction caused patient to be hospitalized.Lot # not provided.Additional information requested.

Manufacturer Narrative

The product does contain a persulfate allergy warning on the box.Without the return product, lot # or answers to the questions listed in an sent email further investigation is not possible.Attempts were made to obtain the information needed for further investigation but we did not receive the information.

• Brand Name: RETAINER BRITE® CLEANING TABLETS-96 CT-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: 15275844
• MDR Text Key: 298414861
• Report Number: 1036212-2022-00001
• 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: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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: RB-92-CASE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/18/2022
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1