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

Catalog Number 728-3022

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 330816689
• Report Number: 2016150-2023-00009
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00889989084832
• UDI-Public: 00889989084832
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male