RETAINER BRITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for RETAINER BRITE manufactured by Dentsply Sirona Orthodontics Inc..

Event Text Entries

[116191136] 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 mexico 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, i 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. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5078826
• MDR Report Key: 7743105
• Date Received: 2018-08-01
• Date of Report: 2015-08-01
• Date of Event: 2018-12-25
• Date Added to Maude: 2018-08-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: RETAINER BRITE
• Generic Name: RETAINER, SCREW EXPANSION, ORTHODONTIC
• Product Code: DYJ
• Date Received: 2018-08-01
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DENTSPLY SIRONA ORTHODONTICS INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit	2018-08-01