MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC. REVEAL CLEAR ALIGNERS; SEQUENTIAL ALIGNERS

Model Number	140-8735
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer complaint form and patient questionnaire regarding the reveal clear aligners standard state that the 77-year-old female patient presented with an allergic reaction.The patient stopped wearing the aligner trays three separate times with several days in between and rinsing the aligners with dawn soap as advised by the dental office, but could not tolerate the aligners due to redness of the oral tissue, swelling of the tongue, difficulty breathing, and tender chapped lips.As stated in the patient questionnaire, no hospital visit was indicated, and no doctor referral, follow-up or prescription medications were required.The patient stopped wearing the trays, took otc benadryl, and has fully recovered.Ortho organizers decided to report this complaint to the fda because the patient took otc medication (benadryl).
Event or Problem Description
The 77-year-old female aligner patient presented with an allergic reaction.The patient stopped wearing the aligner trays three separate times with several days in between and rinsing the aligners with dawn soap as advised by the dental office, but could not tolerate the aligners due to redness of the oral tissue, swelling of the tongue, difficulty breathing, and tender chapped lips.

• Brand Name: REVEAL CLEAR ALIGNERS
• Common Device Name: SEQUENTIAL ALIGNERS
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave.; carlsbad CA 92008
• Manufacturer (Section G): BRASSELER USA DENTAL; 1 brasseler blvd.; savannah GA 31419
• Manufacturer Contact: nicole rajek ; 1822 aston ave.; carlsbad, CA 92008 ; 7604488600
• MDR Report Key: 19168718
• Report Number: 2081322-2024-00001
• Device Sequence Number: 7456110
• Product Code: NXC
• UDI-Device Identifier: 00190707096946
• UDI-Public: 00190707096946
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K210613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: Other
• Device Model Number: 140-8735
• Device Catalogue Number: 140-8735
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female