MAUDE Adverse Event Report: SDS DE MEXICO SPARK 20; Aligner, sequential

Catalog Number	728-3022
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an allergic reaction to trugen xr aligners.Patient experimented eyes swollen and water since 1st day wearing the aligners.Based on doctor's professional opinion, it is considered serious injury due to the patient had eyes swollen.It was prescripted antihistamine.Patient is fully recovered.The problem was with trugen x material used in refinement, patient didn't present any allergic reaction with trugen material.Re-order was made with trugen material to continue with treatment.

• Brand Name: SPARK 20
• Common Device Name: Aligner, sequential
• Manufacturer (Section D): SDS DE MEXICO; cto. sur 31, nelson; mexicali, baja california 21395 ; MX 21395
• Manufacturer (Section G): SDS DE MEXICO; cto. sur 31, nelson; mexicali, baja california 21395 ; MX 21395
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea 92821
• MDR Report Key: 18352251
• Report Number: 2016150-2023-00009
• Device Sequence Number: 15575655
• Product Code: NXC
• UDI-Device Identifier: 00889989084832
• UDI-Public: 00889989084832
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/18/2023

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: 728-3022
• Device Lot Number: 1160600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male