MAUDE Adverse Event Report: SDS DE MEXICO SPARK 20 - DUAL ARCH

Catalog Number 728-3020

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

It was reported patient had an allergic reaction to the first set of aligners.Symptoms patient experienced were not provided.Based on doctor's professional opinion allergic reaction can be a serious injury for possible anaphylaxis.Patient did not go to the hospital and was not referral to another type of doctor.Patient is fully recovered.

• Brand Name: SPARK 20 - DUAL ARCH
• Type of Device: SPARK 20 - DUAL ARCH
• 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
• MDR Report Key: 18095481
• MDR Text Key: 327669359
• Report Number: 2016150-2023-00007
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00889989083453
• UDI-Public: 00889989083453
• 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: 11/08/2023

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: 728-3020
• Device Lot Number: 1488803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male