MAUDE Adverse Event Report: SDS DE MEXICO SPARK ADVANCED

Catalog Number	728-3030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient had a severe allergic reaction.Patient experimented severe swelling of upper and lower lips four (4) days after starting the first aligner of the initial set.Based on doctor's professional opinion, allergic reaction is considered adverse event because if the patient continue with wearing the aligners the allergy could worsen.Patient did not seek medical attention with a doctor and did not go to hospital for these symptoms.Patient took a heavy dose of benadryl to reduce the swollen of the lips.Doctor requested the patient not to wear the aligners and the symptoms disappear.Patient is fully recovered but currently is not wearing the aligners.

• Brand Name: SPARK ADVANCED
• Common Device Name: SPARK ADVANCED
• 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, CA 92821 ; 7148174396
• MDR Report Key: 18368708
• Report Number: 2016150-2023-00010
• Device Sequence Number: 7617748
• Product Code: NXC
• UDI-Device Identifier: 00889989083460
• UDI-Public: 00889989083460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/20/2023

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: 728-3030
• Device Lot Number: 1944385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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: 57 YR
• Patient Sex: Male